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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
see attachment
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
CD-1
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 1% w/v aqueous methylcellulose
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males: 2000 mg/kg bw
5 females: 2000 mg/kg bw
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:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
There were no deaths and no clinical signs of reaction to treatment with the test substance.
Gross pathology:
Effects on organs:
No abnormalities were recorded at the macroscopic examination on Day 15.
Other findings:
Signs of toxicity (local):
Slight dermal irritation (Grade 1 erythema with or without Grade 1 oedema) was observed in three males and two females, resolving completely by either Day 3 or Day 5. In addition, desquamation was seen in one further animal on Day 4. No dermal reactions were observed in the remaining four animals throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats of Cl-TTA Solid was demonstrated to be greater than 2000 mg/kg bodyweight.
CI-TTA Solid will not require labelling with the risk phase R2l "Harmful in contact with skin", in accordance with Commission Directive 93/21/EEC equivalent to hazard statement H312 of REGULATION (EC) No 1272/2008

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