Reaction mass of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine and N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-1-amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source

Data source

Reference

Reference Type:

secondary source

Title:

Acute dermal toxicity study of test chemical was performed in rabbits.

Author:

U.S. Environmental Protection Agency

Year:

2003

Bibliographic source:

Robust Summary & Test Plans

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute dermal toxicity study of test chemical was performed in rabbits according to OECD Guide-line 402 "Acute Dermal Toxicity".

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,9-Bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9 diphosphaspiro[5.5]undecane

Cas Number:

26741-53-7

Molecular formula:

C33H50O6P2

IUPAC Name:

3,9-Bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9 diphosphaspiro[5.5]undecane

Details on test material:

- Name of test material (IUPAC name): 3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Common name: Phosphorous acid, cyclic neopentanetetrayl bis(2,4-di-tert-butylphenyl)ester
- Molecular formula: C33H50O6P2
- Molecular weight: 604.7 g/mol
- Smiles notation: O1P(OCC2(COP(OC2)Oc2c(cc(cc2)C(C)(C)C)C(C)(C)C)C1)Oc1c(cc(cc1)C(C)(C)C)C(C)(C)C
-InChl:1S/C33H50O6P2/c1-29(2,3)23-13-15-27(25(17-23)31(7,8)9)38-40-34-19-33(20-35-40)21-36-41(37-22-33)39-28-16-14-24(30(4,5)6)18-26(28)32(10,11)12/h13-18H,19-22H2,1-12H3
- Substance type: Organic

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Details on test animal:
TEST ANIMALS
- Age at study initiation: Approximately 11 weeks old
- Weight at study initiation: 2014 - 2224 g at study initiation

Administration / exposure

Type of coverage:

other: dermal

Vehicle:

not specified

Details on dermal exposure:

No data available

Duration of exposure:

No data available

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Total: 10 animals

Control animals:

not specified

Details on study design:

Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed in treated rabbits at 2000 mg/kg bw.

Mortality:

No mortality was observed in treated rabbits at 2000 mg/kg bw.

Clinical signs:

5 rabbits had abnormal defecation (soft stool, mucoid feces) on day 0 or 1. One of these animals also had wet, and subsequently, dry brown urogenital matting. These findings were considered to be a result of the bandage/restraint procedures used and not related to the test material. An additional spontaneaous occurrence of soft stool was noted on day 9 for one animal. There were no other findings.
The test material induced generally very slight to slight erythema on all rabbits and very slight to slight edema on 8 rabbits. There was a single occurrence of moderate erythema at the day 1 observation. Desquamation was present on five sites by day 7. There were no other dermal findings. One site had very slight erythema at study termination (day 14).

Body weight:

There were no remarkable changes or differences noted in body weights during the study.

Gross pathology:

In necropsy findings, accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for four animals at the terminal necropsy.
There were no other gross necropsy findings for all examined tissues.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The LD50 value was considered to be >2000 mg/kg bw,when 10 male and female New Zealand white rabbits were treated with test chemical according to OECD Guide-line 402 "Acute Dermal Toxicity" by dermal application.

Executive summary:

In acute dermal toxicity study,10 male and female New Zealand white rabbits were treated with test chemical in the concentration of 2000 mg/kg bw according to OECD Guide-line 402 "Acute Dermal Toxicity"by dermal application for 14 days of observation period.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.5 rabbits had abnormal defecation (soft stool, mucoid feces) on day 0 or 1. One of these animals also had wet, and subsequently, dry brown urogenital matting. These findings were considered to be a result of the bandage/restraint procedures used and not related to the test material. An additional spontaneaous occurrence of soft stool was noted on day 9 for one animal. There were no other findings. The test material induced generally very slight to slight erythema on all rabbits and very slight to slight edema on 8 rabbits. There was a single occurrence of moderate erythema at the day 1 observation. Desquamation was present on five sites by day 7. There were no other dermal findings. One site had very slight erythema at study termination (day 14). There were no remarkable changes or differences noted in body weights during the study. In necropsy findings, accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for four animals at the terminal necropsy. There were no other gross necropsy findings for all examined tissues.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rabbits were treated with test chemical by dermal application.