Formaldehyde, polymer with benzenamine, hydrogenated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 40CFR Part 158 Series 81-2, EPA Pesticide Assessment Guidelines. F 1984

Deviations:

no

Principles of method if other than guideline:

The test substance was dosed at a level of 1.0 g/kg. A group of animals (5 male 5 female) with healty intact skin was used. The substance was applied to approxinately 10% of the body surface.of each animal. The dressings were removed after 24 hours and observed over a period of 14 days for any sign of toxicity.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine

EC Number:

603-894-6

Cas Number:

135108-88-2

Molecular formula:

Exact identification is not feasible

IUPAC Name:

2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine

Test material form:

liquid: viscous

Details on test material:

The concentration of PACM oligomers (Formaldehyde, polymer with benzenamine, hydrogenated) in isopropanol was 70%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

The New Zealand White rabbit, weighing 2.0 to 3.0 kg, was used for this study. The animals were obtained
from Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License #23-BL).
The animals were individually housed and maintained in accordance with standards set forth in the Guide for
the Care and Use of Laboratory Animals (NIH Publication No. 86-23). The rabbits were acclimated to the
laboratory for at least 5 days prior to dosing.

Temperature: 60°F - 75°F
Relative Humidity: 30-80%
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water were provided ad libitum. Based on our current
knowledge, no contaminants are known to be in this diet or water which might be expected to
interfere with the objectives of the study.
Caging: Stainless steel elevated wire mesh flooring, 1 rabbit/cage.
The animals were individually identified by an ear tag and each cage was identified with a cage card.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Isopropanol

Details on dermal exposure:

The test article was dosed as supplied, at a dose level of 1.0 g/kg
A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. Approximately 24 hours before
testing, the fur was clipped from the backs of the test animals.
All rabbits were weighed and the correct amount of test article was applied to approximately 10% of the
body surface on each animal. The treated area was covered with a large porous gauze patch and wrapped
with an occlusive material and held in place with an elastic bandage to ensure that the animal did not
ingest the test article. The dressings were removed after 24 hours and any excess material removed, where
practical, using water or an appropriate solvent.

Duration of exposure:

24 hours

Doses:

1 g/kg

No. of animals per sex per dose:

5 male
5 female

Control animals:

no

Details on study design:

The animals were observed for a 14 day period, for signs of toxicity (systemic and topical) and for
mortalities. Animals were observed frequently during the first day of dosing, and twice per day (morning
and afternoon) on weekdays. On weekends and holidays, animals were observed once per day.
Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. The
animals were euthanized using T-61@ at the conclusion of the observation period. Gross necropsies were
performed on all animals.

Statistics:

no data available

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Males: Necrotic skin and severe edema was noted after unwrapping at 24 hours. At 7 days 5/5 animals exhibited necrotic skin and severe edema. At 14 days, 3/5 animals exhibited necrotic skin and severe edema, 1/5 animals exhibited peeling necrotic skin and

Gross pathology:

No gross abnormalities were noted for 5/5 males necropsied at the conclusion of the 14 day observation period.
No gross abnormalities were noted for 5/5 females necropsied at the conclusion of the 14 day observation period.

Other findings:

none

Applicant's summary and conclusion

Conclusions:

The acute dermal toxicity of Formaldehyde, polymer with benzenamine, hydrogenated appears to be greater than 700 mg/kg. At this dose level the test material was corrosive to skin but no mortalities occurred.

Executive summary:

Formaldehyde, polymer with benzenamine, hydrogenated when dosed at a 70% concentration in isopropanol and studied in male and female albino rabbits combined was corrosive to the skin and had an acute dermal LD50 >1000 mg/kg.

The LD50 in male and female rabbits, based on the substance (formaldehyde, polymer with benzenamine, hydrogenated) appears to be >700 mg/kg.