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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Test start date: 06 December, 1989; Test end date: 27 December, 1989; Study completion date: 27 February 1990
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Reaction mass of 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-bromo-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium hydroxide
Reaction mass of 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-bromo-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium hydroxide
Test material form:
Specific details on test material used for the study:
Substance identified as: FAT 31064/F
- Batch No.: EN 158496.82 / HEW 133/6
- Description: Powder
- Stability of test article: Stable; expiration date: November 1994
- Stability of test article dilution: Stable for at least 2 hours
- Safety Precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety.

Test animals

Han. (outbred, SPF-quality)
Details on test animals or test system and environmental conditions:
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Füllinsdorf
- Initial body weight range: males: 219 - 230 g, females: 195 - 204 g.
- Initial age: males: 10 weeks, females: 12 weeks

Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with temperature 22+/-3 degrees centigrade, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music/light period.

Pelleted standard Kliba 343, Batch 60/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.

Water: Community tap water from Itingen.

Acclimatisation: One week under laboratory conditions, after veterinary examination.

Administration / exposure

Type of coverage:
Details on dermal exposure:
The test article was placed into a glass beaker on a tared Mettler PE 360 balance and the vehicle (bi-distilled water) was added. A weight/volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke and Kunkel, D-7813 Staufen).
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke and Kunkel, D-7813 Staufen).
The preparation was made immediately prior to each dosing.

Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface.
On test day 1 the test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water, dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes and Sanderson (Noakes, D.N. and Sanderson, D.M. "A Method for Determining the Dermal Toxicity of Pesticides". Brit. J. Industr. Med., 26, 59-64, 1969).

Application volume/ kg body weight: 4 mL at 2000 mg/kg bw
Duration of exposure:
24 h
2000 mg/kg bw (single application)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
Mortality / Viability: Four times during test day 1, and daily during days 2-15.
Body Weights: Test days 1 (pre-administra'tion), 8 and 15.
Clinical Signs:
Each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded. Due to the 24-hour semi-occlusive treatment, the local findings were observed starting with day 2 of test.

Necropsy: Necropsies were performed by experienced prosectors. All animals were necropsied. All animals were killed by intraperitoneal injection of sodium pentobarbitone.
The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortaility was observed.
Clinical signs:
other: The following local signs were observed: All treated males - skin/fur: skin blue (back); females - skin/fur: skin blue (back) (for all 5); scales (back) ( for a single female). The animals showing scales had recovered after 12 observation days. Blue disco
Gross pathology:
No macroscopical organ changes were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The acute dermal LD50 of FAT 31064/A was determined to be >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity potential of FAT 31064/A was assessed in a study carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal". In this study, the test substance was administered to five rats of each sex by dermal application at 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. No systemic symptoms were seen. Bluish skin on back was observed after the removal of the patches in all exposed animals. Female no. 6 showed loss of weight between days 1 and 8 of test. The body weight gain of the other animals were not affected throughout the study by test article treatment. No macroscopical organ changes were noted during the necropsies. Based on the findings of the study, the acute dermal LD50 for FAT 31064/A was determined to be >2000 mg/kg bw.