Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Oct 2006 - 08 Nov 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test site not covered, no necropsy performed; not conducted in compliance with GLP; only limited information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(adopted 24 Feb 1987)
Deviations:
yes
Remarks:
(test site was not covered, ingestion of test material was prevented by complete immobilisation of animals, no necropsy was performed, no details on test material purity given)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 69
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 10% of total body surface

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: no
- For solids, paste formed: yes

OTHER
- Approximately 24 hours before the test, the dorsal hair of animals was removed by cutting and scraping.
- To keep the product in contact with the animals' skin and avoid ingestion or inhalation, the animals were housed individually in small boxes, in order to hinder any movement of animals.
Duration of exposure:
24 h
Doses:
4000 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: Days 1, 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred throughout the study period.
Clinical signs:
There were no clinical signs noted in any of the animals throughout the study period.
Body weight:
All animals showed weight gain during the trial period. The weight variation observed among males was higher than that observed among females. Other changes were not observed in animals treated during the 14-day trial.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified