Benzo[rst]phenanthro[10,1,2-cde]pentaphene-9,18-dione, reaction products with 1-chlorododecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.

EC Number:

270-145-4

EC Name:

Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.

Cas Number:

68411-75-6

Molecular formula:

Unspecified

IUPAC Name:

Dinaphtho[1,2,3-cd:1',2',3'-lm]perylene-9,18-dione, dodecyl derivs.

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Fluorescent Yellow *131, 1577-123

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Ten young adult New Zealand White rabbits were obtained from New York State Rabbit Development, Hartwick, New York for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEN Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in environment-controlled rooms and provided NIH Animal Feed A (certified) and water ad libitum. Animals were identified with ear tags and color coded cage cards. All animals were acclimated a minimum of 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Procedure:
On the day prior to dosing, the back and flanks of each rabbit were clipped free of fur with electric clippers. The test article was administered under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette binder, all securely held in place with masking tape. The occlusive binder was applied to maintain contact and minimize evaporation of the test article. After an exposure period of 24 hours, the binders were removed. The exposure sites were then gently wiped with clean gauze to remove as much non-absorbed test article as possible.

Duration of exposure:

24h

Doses:

2 gm/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Procedure:
On the day prior to dosing, the back and flanks of each rabbit were clipped free of fur with electric clippers. The test article was administered under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette binder, all securely held in place with masking tape. The occlusive binder was applied to maintain contact and minimize evaporation of the test article.

Observations:
After an exposure period of 24 hours, the binders were removed. The exposure sites were then gently wiped with clean gauze to remove as much non-absorbed test article as possible. One-half hour after unwrapping, the exposure sites were examined and scored spearately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Skin Reaction code in Appendix 1. The exposure sites were again examined and scored at 48 and 72 hours post-dose. If irritation persisted at the 72 hour post-dose observation period, the sites were furthered examined at 4,7, 10, and 14 days post-dose or until all sites returned to normal, whichever occured first.

All animals were observed frequently on the day of dosing and twice daily for the remainder of the study. All external signs of toxicity or pharmacological effects were noted. Body weights were recorded initially, on days 8 and 15 or at death.

Necropsy:
All animals that died during the study, and all survivors at termination (day 15) were subjected to gross necropsy and abnormalities were noted.

Statistics:

Data Evaluation:
In evaluating the average irritation, scores for individual intact exposure sites were recorded spearately for each of the scoring time intervals. Based on the 24, 48 and 72 hours post-dose observation periods, a total for erythema and eschar formation was added to a total for edema, then divided by 3 to yield the individual animal score. The mean of the ten scores was calculated and this represents the mean primary score.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None observed

Clinical signs:

other: 1 male had soft stool and 2 other males exhibited anorexia temporarily during the study.

Gross pathology:

There were no noteworthy findings

Any other information on results incl. tables

Skin Irritation Scores

	Obs. Post-dose hrs	Rabbit Number
		Males					Females
		3276	3280	3282	3283	3286	3344	3346	3358	3359	3360
Erythema	24.5	0	0	0	0	0	0	0	0	0	0
	48	0	0	0	0	0	0	0	0	0	0
	72	0	0	0	0	0	0	0	0	0	0
Edema	24.5	0	0	0	0	0	0	0	0	0	0
	48	0	0	0	0	0	0	0	0	0	0
	72	0	0	0	0	0	0	0	0	0	0
	Summary of Irritation Potential
Erythema sub-total		0	0	0	0	0	0	0	0	0	0
Edema sub-total		0	0	0	0	0	0	0	0	0	0
Total for Erythema and Edema		0	0	0	0	0	0	0	0	0	0
Individual Animal Score		0	0	0	0	0	0	0	0	0	0

Mean Primary Irritation Score: 0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Application of the test material to the skin of rabibits at a dose level of 2 g/kg did not produce lethality. The LD50 for this compounds is consequently >2 g/kg.

Executive summary:

Fluorescent Yellow *131, 1577-123, was evaluated for acute dermal toxicity in male and female New Zealand White rabbits. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight. All animals survived the 15 day post-dose observation period. Based on this result, the acute dermal LD50 of the test article is considered to be greater than 2.0 g/kg. In addition, the above referenced test article is considered to be non-irritating to the skin of rabbits.