Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
05 Jan - 19 Jan 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD) (limited data on test substance).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limited data on test substance
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
limited data on test substance
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm laboratories ltd., Derby, UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Straw colored liquid- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River, UK- Age at study initiation: 8 - 12 weeks- Weight at study initiation: males: 202 - 217 g (male) and 202 - 212 g (female)- Housing: individually housed in suspended polypropylene cages for the time of exposure and in groups of five, by sex, for the reminder of the study.- Diet: ad libitum, Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, UK- Water: ad libitum- Acclimation period: minimum 5 dENVIRONMENTAL CONDITIONS- Temperature (°C): 19-21 (18 at one ocasion, this was not considered relevant for the study)- Humidity (%): 47-67- Air changes (per hr): 15 - Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE- Area of exposure: back and flanks - % coverage: approx. 10% of total body surface- Type of wrap if used: gauze secured with self adhesive bandageREMOVAL OF TEST SUBSTANCE- Washing (if done): wiping with cotton wool moistened with distilled water- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: 0.5 h; 1 h; 2 h and 4 h after dosing and daily thereafter for 14 days. Weighing on Days 0, 7 and 14.- Necropsy of survivors performed: yes- Other examinations performed: Skin reactions according to Draize Scoring System (1977)
Statistics:
Not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
CLP: not classifiedDSD: not classified