1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD & GLP guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

EC Number:

273-227-8

EC Name:

1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

Cas Number:

68953-84-4

Molecular formula:

C18-20H16-20N2

IUPAC Name:

Reaction mass of N-phenyl,N'-o-tolyl-phenylene diamine, N,N'-diphenyl-p-phenylene diamine and N,N'-di-o-tolyl-phenylene diamine

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rabbits of both sexes were received from Myrtle's Rabbitry, Tennessee as adults. Animals were provided Purina rabbit chow #5322 ad libitum as was drinking water. Animals were quarantined for 5 days prior to study initiation. Male rabbits weighed 2.64 kg at study initiation while females weighed 2.95 kg. Rabbits were housed individually, and maintained in environment of 66-73 degrees F & 35-61% humidity. The photoperiod was 12 hr light/12 hr dark with 10 - 12 air changes per hours.

The in-life portion of the study was Jan 17 - 31, 1995.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The area of exposure was ~10% of body surface (dorsal surface of back). This area was calculated with the equation - Body surface area (cm2) = 9 x [body wt (grams)] exp 0.6667. The 10 % area was then delineated on a 4-ply porous gauze. The chemical was applied to this area of the gauze, moistened with equal volume of water (1 mL water per gram chemical), and applied to the backs of the test rabbits. The gauze was then covered with plastic wrap, and then an elastic wrap to secure the site. Upon completion of a 24 hr exposure period, the site was cleaned with gauze moistened with water.

The amount of solid test material applied to the skin site was equivalent to 2000 mg/kg.

Duration of exposure:

Exposure was 24 hr

Doses:

2000 mg/kg, single dose

No. of animals per sex per dose:

5 rabbits per sex

Control animals:

not required

Details on study design:

Rabbits were observed twice daily for mortality for a 14-day period. Each rabbit was weighed on Days 0, 7, & 14. Clinical signs were monitored once daily. All animals were necropsied at study termination. No other assessments were conducted.

Results and discussion

Preliminary study:

Because of negligible oral toxicity in rats, a limit test for dermal exposure was considered justified.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0/10 rabbits

Clinical signs:

other: No behavioral or gross abnormalities were observed. There was an indication of edema (grade 1 in 9/10), and erythema (grade 1 in 10/10, grade 2 in 6/10 - transient 1-2 days).

Gross pathology:

No chemical related findings.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The dermal LD0 = 2000 mg/kg, and LD50 >2000 mg/kg

Executive summary:

The acute dermal toxicity of test chemical was assessed in rabbits of both sexes in a limit test per OECD & GLP guidelines. There were signs of dermal irritation at the application site, including edema and erythema. No chemical-related adverse clinical (behavioral or gross) effects were observed including mortality, body weight changes, or necropsy observations. The dermal LD0 = 2000 mg/kg, and LD50 >2000 mg/kg.