Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-Nov-05 to 2002-Dec-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv Rot F00-0124

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=257g; F=207g
- Housing: transparent macrolon cages (type III) on soft wood granulate in an air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five 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 a two-ply gauze and an aluminum foil (6 x 8 ern) 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 Rot F00-0124 was moistened with 0.4 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 weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
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 symptoms were observed after administration of 2000 mg/kg body weight.
Body weight:
1 female animal showed a slight loss of body weight during the first week of the study, which returned to normal until the end of the study.
In all other animals development of body weight was not impaired.
Gross pathology:
No gross patholgoy changes
Other findings:
The skin of the animals showed violett discolorations from day 2 up to day 6 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 median LD50 of Reactive Red F00-0124 for male and female Sprague Dawley rats is > 2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study, groups of Hsd Sprague Dawley rats, 5/sex, were dermally exposed to Reactive Red F00-0124 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.

Dermal LD50:

Males = >2000 mg/kg body weight

Females = >2000  mg/kg body weight

Combined = >2000 mg/kg body weight 

Reactive Red F00-0124 is of low Toxicity based on LD50 is >2000 mg/kg body weight.