Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test species/strain/quality: Rat/Wistar/Crl:WI (Han) SPF
Reasons for selection: Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
Age on day 0: Young adult animals. (Male animals approx. 8 weeks, females approx. 12 weeks)
Sex: Males and females
Supplier: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Arrival in the testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Identification: Individual identification by cage cards and tail marking.
Body weight on day 0: Animals of comparable weight.

Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Day/night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Makrolon cage, type III
Number of animals per cage: Single housing
Feeding: VFR1(P); SDS Special Diets Services, 67122 Altrip, Germany
Drinking water: Tap water ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The undiluted test item was applied to clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by a semi-occlusive dressing.
Duration of exposure:
24 hours.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

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 occured.
Clinical signs:
No systemic clinical signs or local effects were observed during clinical examination.
Body weight:
The mean body weight of the male animals increased throughout the study period within the normal range. The mean body weights of the female animals stagnated during the first post-exposure observation week probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw. According to EU CLP classification guidelines the test substance is not classified as an acute dermal toxin.
Executive summary:

The acute dermal toxicity of the test substance to Wistar rats was determined in accordance with the OECD Guideline for Testing of Chemicals 402. In the acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item Pluriol BP 40E to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred during the study and no signs of systemic toxicity or skin effects were observed in the animal. The mean body weight of the male animals increased throughout the study period within the normal range, the mean body weights of the female animals stagnated during the first post- exposure observation week probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw. According to EU CLP classification guidelines the test substance is not classified as an acute dermal toxin.