Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,2-diol
EC Number:
226-285-3
EC Name:
Pentane-1,2-diol
Cas Number:
5343-92-0
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,2-diol

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 184 g - 214 g
- Housing: animals were caged individually in Macrolon cages type 2 with standardized soft wood bedding
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55 % +/- 15 %
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: skin of the back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: after an exposure period of 24 hours

TEST MATERIAL
- volume applied: 2 ml /kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
no
Details on study design:
Approxinately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper. The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze lined occlusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarmwater. Thereafter the reaction of the skin was appraised repeatedly. Animals were observed for a period of 14 days or until all symptoms have disappeared, whichever lasts longer.
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable , the LD50 including the 95 % confidence limit were computed by the logit method.

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
Clinical signs:
Sedation (up to 5 hours after administration), dyspnoe (up to 8 days after administration), exophtalamus (up to 7 days after administration), ruffled fur (up to 8 days after administration), erythema (from day 2 on up to 5 days after administration) and a curved body position (up to 5 days after administration) were observed.
The animals recovered within 9 days.
Gross pathology:
No compound related gross organ changes were observed

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Upon an acute dermal administration and a 14 day post-treatment observation period, the following LD50 was determined for the test item: LD50 > 2000 mg/kg bw

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