[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Molecular formula:

C26H20.85Br1.82Na1.97N3O9S2

IUPAC Name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 79579176, DCT # 80226

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approximately 8 to 11 weeks
- Housing: The rabbits were individually housed in elevated wire mesh cages in temperature controlled rooms reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): water from bottles were available ad libitum
- Acclimation period: The rabbits were equilibrated for at least 7 days.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

24 hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. The rabbits were returned to their cages overnight. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding.

Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing, the test site were graded for skin irritation .

Evaluation of skin reactions:
Erythema & Eschar Formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Edema Formation:
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 millimeter): 3
- Severe edema (raised more than 1 millimeter and extending beyond the area of exposure): 3

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

4 rabbits (2 males and 2 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rabbits observed daily and body weight were recorded pretest and at 7 and 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died at day 1 of the experiment (Animal number 3).

Clinical signs:

other: - Few or no feces present in pan: Animal #2, days 9-14. - Lethargy: Animal #2, days 11-14. - Ptosis: Animal #2, day 13. - Yellow nasal discharge: Animal #4, days 5 & 6.

Gross pathology:

Necropsy observations:
- Animals 1&4: normal.
- Animal 2: Bloated intestines.
- Animal 3: Brown exudate, anogenital area, yellow areas on intestines, dark & mottled liver, dark areas on lungs, large spleen.

Any other information on results incl. tables

Individual body weight and skin grades:

Rabbit number	Sex	Weights-kg
		0	7	14
1	M	1.9	2.3	2.4
2 ab	M	2.3	2.3	2.4
3	F	2.1	Died on day 1
4 ab	F	2.5	2.5	2.6

ab: Abraded

Redness			Edema
25 h	7	14	25 h	7	14
0	0	0	0	0	0
1	1	0	0	0	0
2	1	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of FAT 40069 in rabbits is greater than 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity was performed for FAT 40069 in rabbits. The test was performed on New Zealand White rabbits at approximately 8 to 11 weeks of age. Twenty-four hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally , scratched the stratum corneum, but did not disturb the derma or produce bleeding. The test material was applied to the backs of 2 male and 2 female rabbits at a dose of 2000 mg/kg bw. The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours. Following removal of the binder at 24 hours, the test site was washed with warm tap water. One hour after washing, the test site were graded for skin irritation. Skin areas were read again at 7 and 14 days. Bodyweights were recorded pretest and at 7 and 14 days: The rabbits were observed daily for 14 days for signs of toxicity and mortality. Necropsies were performed on all rabbits. Mortality was observed in 1/4 - Animal 3, day 1. Few or no feces present in pan: Animal 2, days 9 -14. In conclusion, the acute dermal LD50 of FAT 40069 in rabbits is greater than 2000 mg/kg bw.