Provisional Peer-Reviewed Toxicity Values (PPRTVs)

4,4'-Methylenebis (2-chloroaniline)

CASRN 101-14-4

PPRTV Toxicity Values Summary Table

Noncancer Assessment

Estimate of Chronic Reference Dose for Oral Exposure (RfD)Last Updated: 08/03/2006
System RfD (mg/kg-day) Basis PoD UF Confidence
Hepatic 2 x 10-3 Increased mean serum ALT and increased nodular hyperplasia of liver LOAEL : 7.3 mg/kg-day 3000 Low
Species Studied: Dog
Duration: 9 years
Principal Study: Stula et al. 1977



Estimate of Subchronic Reference Dose for Oral Exposure (RfD)Last Updated: 08/03/2006
System RfD (mg/kg-day) Basis PoD UF Confidence
Hepatic 2 x 10-3 Increased mean serum ALT and increased nodular hyperplasia of liver LOAEL : 7.3 mg/kg-day 3000 Low
Species Studied: Dog
Duration: 9 years
Principal Study: Stula et al. 1977
Note: Chronic value was adopted as the subchronic value.



Estimate of Chronic Reference Concentration for Inhalation Exposure (RfC)Last Updated: 08/03/2006
Data inadequate for deriving a chronic RfC.


Estimate of Subchronic Reference Concentration for Inhalation Exposure (RfC)Last Updated: 08/03/2006
Data inadequate for deriving a subchronic RfC.


Cancer Assessment

Weight of Evidence for CancerLast Updated: 08/03/2006
LI - Likely to be carcinogenic to humans


Estimate of Carcinogenic Risk from Oral ExposureLast Updated: 08/03/2006
Oral Slope Factor: 1 x 10-1 per mg/kg-day
Tumor site(s):
Cancer: Adenoma, adenocarcinoma, epideroid carcinoma
Species Studied: Rat
Duration: 2 years
Principal Study: Kommineni et al. 1978
Note: Based on the BMD10. For chemicals that have been determined to be carcinogenic by a mutagenic mode of action, sample calculations for estimation of risk are supplied in the Supplementary Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens, March, 2005, especially Example 2, which presents a sample calculation for a total lifetime exposure (0-70 years). Both the exposure and the increased potency in early life exposures must be utilized by the risk assessor in the field to determine risk. For oral exposure (OSF), the dose (Dose= Intake Rate x Concentration in media / Body Weight; e.g. mg/kg-day; Risk = Dose x ADAF x Duration factor x OSF) must be calculated for each age bracket (0-<2, 2-<16, and 16-70 years). The dose for each life stage is utilized to determine risk as indicated above using the appropriate ADAF (10, 3, 1), and duration factor (2/70, 13/70 and 55/70). The Exposure Factors Handbook indicates that the average weight for human male and female in the age bracket of 0-<2 is 7.6 Kg, for 2-<16 is 36.4 Kg and for 16-70 is 70Kg. Intake rates for each life stage and concentrations in the media must be determined by the risk assessor in the field.

Provisional Peer-Reviewed Toxicity Values (PPRTVs)