Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-Apr-01 to 1998-Apr-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
see below

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmlann, Gartenstrasse 27, 33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=259g; F=217g
- Housing: in fully air-conditioned rooms in macrocolon cages (type III) on soft wood granulate, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottels, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light):12 hours dark / 12 hours light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 30 cm²
- Type of wrap if used: the test substance was moistened on an aluminum foil (6x8 cm) and distributed as uniformly as possible. The foil was held in place with an elastic plaster bandage fixed around the animal's body.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Reaktiv Marineblau FC 63805 was moistened with 0.45 ml deionized water
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/ kg body weight
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekend and public holidays only once.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs
Body weight:
Development of body weight was not impaired. (All animals gained weight: M=49.4g; F=13.8g)
Gross pathology:
No gross pathology changes
Other findings:
- Other observations: The skin of the animals showed red discolorations up to day 13 of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD0 of Reactive Red FC 73270 for male and female Sprague Dawley rats is >2000mg/kg body weight.
Executive summary:

In an acute dermal toxicity study according to OECD 402, HSD Sprague Dawley rats, 5/sex, were dermally exposed to the test substance in deionized water for 24 hours to 30 cm² of body surface area at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.

 

The acute dermal toxicity testing in the rat yielded a median lethal dose above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg bw neither deaths nor symptoms occurred. The skin surface of the animals was large discoloured red from staining with the test substance. This discolouration had not disappeared up to the end of the study in three animals.

Body weight was above the initial weight during the whole observation period.

The animals killed at the end of the observation period showed no macroscopically visible changes.

 

Dermal LD0 and LD50:

Males             >2000 mg/kg body weight

Females          >2000 mg/kg body weight

Combined      >2000 mg/kg body weight

 

Reactive Red FC 73270 is of low toxicity based on LD0 > 2000 mg/kg body weight.