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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:
2007-09-10 to 2007-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guidelines for the Testing of Chemicals, No. 402.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987-02-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
92/69/EC
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch: E06000594
Purity: (GC): 99.9 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Rat, Wistar HsdCpb: WU, males (m) and females (f)
Breeder: F. Winkelmann, DE-33178 Borchen
Age: approx. 9 - 10 weeks

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
paraffin oil
Details on dermal exposure:
Backs and abdomens of the rats shaved with electric hair clipper, not later than 1 h before treatment.
Directly before administration test material was moistened with liquid paraffin, spread on the shaven skin, area ca. 6x6 cm, covered with gauze patch, kept in place by self-adhesive fabric. After exposure period of 24 hours gauze and adhesive fabric were removed and any remaining test material wiped off carefully.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (limit test)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Test substance was tested for acute toxicity in 5 male and 5 female rats after dermal administration of 2000 mg/kg body weight. Directly before administration the test material was moistened with liquid paraffin, spread on the shaven skin and covered with a gauze patch, which was kept in place by self-adhesive fabric. After exposure time of 24 hours the gauze and adhesive fabric were removed, wiping off any remaining test material.
Statistics:
Body weight data were recorded with the validated PC-program "AKUDAT", statistical evaluations of body weight development carried out with "TOX 511A".

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths during the course of the study.
Clinical signs:
No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg.
Body weight:
The body weight development was inconspicuous. All rats were weighed before treatment and on days 2, 4, 6, 8, 11, 13 and 15 of the experimental part.
Gross pathology:
The gross pathological examination revealed no organ alterations.
Other findings:
None.

Any other information on results incl. tables

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study, so the lethal dose is expected to be > 2000 mg/kg bw. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.
Executive summary:

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study, so the lethal dose is expected to be higher than the limit dose tested. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.