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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
read across justification and attach document below.
Cross-reference
Reason / purpose:
read-across source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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
Specific details on test material used for the study:
Propylidenetrimethanol, propoxylated mw 310; clear,
colourless, viscous liquid; purity not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: least 200g
- Housing: Individually during exposure and in gropus of 5 by sex for the remainder of the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 changes
- Photoperiod (hrs dark / hrs light): 12 hours light and dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn skin
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: Self adhesive bandage


REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period, treated skin and surrounding hair wiped with distilled water

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not required

Results and discussion

Preliminary study:
Not reported
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
No signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
None

Any other information on results incl. tables

No deaths and no signs of systemic toxicity were noted. Animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of propoxylated propylidenetrimethanol was investigated in the rat. No deaths, signs of toxicity, bodyweight effects or necropsy findings were reported following exposure to the limit dose of 2000 mg/kg bw. The acute dermal LD50 was therefore found to be >2000 mg/kg bw under the conditions of this study.