Registration Dossier

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: Peer reviewed publication. The method used is similar to OECD 402, but predates GLP.

Data source

Reference
Reference Type:
publication
Title:
The toxicity of allyl alcohol.
Author:
Dunlap, M.K., Kodama, J.K., Wellington, J.S., Anderson, H.H., Hine, C.H.
Year:
1958
Bibliographic source:
AMA Archives of Industrial Health. 18:303-311

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only three rabbits per group used, observation period not less than 10 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl alcohol
EC Number:
203-470-7
EC Name:
Allyl alcohol
Cas Number:
107-18-6
Molecular formula:
C3H6O
IUPAC Name:
prop-2-en-1-ol
Details on test material:
Allyl alcohol was 98.5% pure and was provided by the Shell Chemical Company. (Impurities are diallyl ether and water).

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 1.3 - 3.9 kg
- Housing: Housed individually in cages
- Diet (e.g. ad libitum): standard pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ad libitum


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- coverage: 3x3 cm
- Type of wrap if used: Rubber dam sealed with rubber cement and subsequently wrapped with toweling and adhesive tape to prevent slipping of the seal.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.025 - 0.20 g/kg
- Constant volume or concentration used: yes
Duration of exposure:
No details
Doses:
0.025 to 0.20 g/kg of allyl alcohol. (no further details).
No. of animals per sex per dose:
Four groups of three rabbits used.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology, gross pathology

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
89 mg/kg bw
Based on:
test mat.
95% CL:
40 - 250
Mortality:
No further details
Clinical signs:
The main clinical sign was described as apathy, along with flushing of the skin. Attitude of bellicosity. Ataxia, convulsions and diarrhoea preceded death in moribund animals.
Body weight:
No details
Gross pathology:
Oedema and congestion of the lungs, visceral congestion (presence of mucous in the intestinal tract), discoloured liver (some necrosis), swollen kidneys.
Other findings:
Histopathological findings: lung congestion, liver damage (congestion and necrosis of the periportal sinusoids, central pallor and necrosis), heme casts and cloudy swelling in the kidney. Rabbits that survived the observation period showed similar lesions to those that died, but less frequently.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study the dermal LD50 of allyl alcohol to rabbits is 89 mg/kg.
Executive summary:

In an acute dermal toxicity study, 4 groups of 3 male albino rabbits were dermally exposed to allyl alcohol to a 3x3cm area at doses of  0.025 to 0.20 g/kg bw.  Animals then were observed for at least 10 days.

 

Dermal LD50Males = 89   mg/kg bw (95% C.L. 40 - 250 mg/kg)