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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 January to 03 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU & OECD test guidance in compliance with GLP.

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:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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): Reaktivgelb FD 08064

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKELMANN
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Mean - Males; 245g (237-261g), Females; 195g (183-216g)
- Fasting period before study: No
- Housing: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate, one 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 bottles, ad libitum
- Acclimation period: at least seven days

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
deionised
Details on dermal exposure:
TEST SITE
- Area of exposure: 30cm3
- % coverage:
- Type of wrap if used: foil with elastic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4ml deionised water
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Males 5
Females 5
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
- Other examinations performed: clinical signs, body weight
Statistics:
None reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study.
Clinical signs:
No symptoms were observed after administration of 2000 mg/kg body weight.
Body weight:
Development of body weight was not impaired.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes
Other findings:
The treated skin areas of the animals were sporadically discolored orange up to the end of the study (day 15).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 2000 mg/kg body weight.
Executive summary:

Study conducted to EU test guidance 92/69/EEC part B3 and OECD test guideline 402 in compliance with GLP.

Based on the results of the study the LD50 > 2000 mg/kg body weight. The substance is not classified as harmful by acute dermal exposure.