Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate

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:

Robust Summary & Test Plans: Color Former Category: Robust Summary

Author:

U.S. Environmental Protection Agency

Year:

2003

Bibliographic source:

Robust Summary & Test Plans: Color Former Category: Robust Summary, EPA HPV Challenge Color Former Category,2 May 2003

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 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) was performed in rats.

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran

Cas Number:

36431-22-8

Molecular formula:

C33H32N2O3

IUPAC Name:

6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran

Details on test material:

- Name of test material (IUPAC name): 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
- Common name: Black XV
- Molecular formula: C33H32N2O3
- Molecular weight: 504.627 g/mol
- Smiles notation: O=C1O[C@@]2(c3c(Oc4c2ccc(N(CC)CC)c4)cc(C)c(Nc2c(C)cc(C)cc2)c3)c2c1cccc2
-InChl:1S/C33H32N2O3/c1-6-35(7-2)23-13-14-26-31(18-23)37-30-17-22(5)29(34-28-15-12-20(3)16-21(28)4)19-27(30)33(26)25-11-9-8-10-24(25)32(36)38-33/h8-19,34H,6-7H2,1-5H3
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):Black XV
- Molecular formula :C33H32N2O3
- Molecular weight :504.627 g/mol
- Substance type:organic

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Age at study initiation: Ten to fourteen weeks old
- Weight at study initiation:
male :210 - 227 grams,
female :200 - 207 grams

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: test material was applied uniformly to an area of shorn skin
- % coverage: approximating to 10% of the total body surface area
- Type of wrap if used: selfadhesive bandage (Hypertie).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material.
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Total:10 animals
2000 mg/kg bw:5 male and 5 female

Control animals:

not specified

Details on study design:

Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: Individual body weights were recorded on the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: Observed over 14 days with deaths and overt signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days

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 at dose 2000 mg/kg bw

Mortality:

no mortality was observed at dose 2000 mg/kg bw

Clinical signs:

other: No signs of systemic toxicity or skin irritation were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute dermal median lethal dose (LD50) of the 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the Sprague-Dawley rat was considered to be >2000 mg/kg bodyweight according to OECD Guideline 402 (Acute Dermal Toxicity).

Executive summary:

In acute dermal toxicity study, 10 male and female Sprague-Dawley rat were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the concentration of 2000 mg/kg bw by dermal applicationaccording to OECD Guideline 402 (Acute Dermal Toxicity).Undiluted test material was used. Skin of animals were moistened with arachis oil B.P. The appropriate amount of test material, as received,was pre-weighed into a glass vial, and applied uniformly to an area of shorn skin approximating to 10% of the total body surface area which had been previously moistened with arachis oil B.P. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of selfadhesive bandage (Hypertie) for 24 hours. After the 24 contact period the bandage was removed and the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material. signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded on the day of treatment and on days 7 and 14.No mortality was observed in treated rats at dose 2000 mg/kg bw.No signs of systemic toxicity or skin irritation were noted during the study. No toxicologically significant effects on bodyweight were noted in the males during the study. One female showed bodyweight loss during the study. No abnormalities were noted at necropsy of animals killed at the end of the study.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8)by dermal application.