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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:
27 Apr 2012 - 16 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot No. : 33HF-201
Product Code : 1326122
Index No. : 056-002-00-7
Analytical purity: > 99%
Physical state: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: National University of Singapore, Centre for Animal Resources (CARE), 7 Perahu Road, Singapore 718836
- Age at study initiation: 7 to 9 weeks old
- Weight at study initiation: male animals: 266 - 310 g, female animals: 220 - 272 g
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324; throughout dosing and observation period
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 30 - 70

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 10 percent of the total surface area

REMOVAL OF TEST SUBSTANCE
- Washing: water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The observation of adverse effects was conducted on each animal during the first 30 minutes, periodically during the first 24 hours (with special attention during the first 4 hours), and periodically thereafter. The body weight of each animal was measured every 7 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no adverse effects observed
Mortality:
No animal died during dosing and observation period.
Clinical signs:
No adverse effect was observed on all the other test animals during observation period.
Body weight:
Body weights were in the normal range.
Gross pathology:
Necropsy was conducted on all the test animals on the termination day. No abnormality was observed
on all the test animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Hence, based on CLP for acute toxicity hazard categories, the substance does not require classification for acute dermal toxicity.