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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles but was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: contract laboratory protocol
GLP compliance:
no
Test type:
other: LD50
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ALFOL 12 Alcohol

- Substance type: Alcohol

- Lot/batch No.: 8429H

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 2.2 to 3.1 kg

- Housing: Individual housing in metal cages which were elevated above the droppings.

- Diet: Purina Rabbit Chow (ad libitum)

- Water: tap water (ad libitum)


IN-LIFE DATES: Not specified.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: applied undiluted
Details on dermal exposure:
TEST SITE

- Area of exposure: Skin of the trunk.

- Type of wrap if used: Plastic binder


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The remaining test material was washed from the animals' bodies which were then carefully blotted dry with absorbent paper hand towels.

- Time after start of exposure: 24 hours


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): maximum dose 1-2 ml/kg, doses 1, 1.5 and 2 g/kg



VEHICLE

- Concentration (if solution): Applied undiluted.
Duration of exposure:
24 hours
Doses:
1, 1.5 and 2 g/kg
No. of animals per sex per dose:
2 male, 2 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were weighed at the beginning and end of the study period.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days.
Statistics:
No statistical analysis of the results was carried out.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 500 - 2 000 mg/kg bw
Mortality:
All deaths occurred within 3 days of exposure.  Number of deaths at each dose: Intact skin 0/2, 1/2 and 2/2, abraded skin 0/2, 0/2 and 2/2. LD50(s) were as follows: Intact skin: 1.5 g/kg; Abraded skin: 1.5 - 2 g/kg; combined intact and abraded 1.5 - 2 g/kg. 
Clinical signs:
At the dose of 1g/kg there were no signs of toxicity. At higher dose levels some prostration was noted. Survivors appeared normal 
72 hours after exposure. Animals at all dose levels showed erythema, wrinkling and desquamation of the application site.
Body weight:
Survivors generally gained weight within expected limits with 2 exceptions; one intact male at 1 g/kg showed a slight weight loss and one abraded male at 1.5 showed a constant weight.
Gross pathology:
In premature decedents there was some general deterioration but no dose-related lesions. Tissues of survivors sacrificed  at the end of the observation period were unremarkable.
Other findings:
No potential target organs were identified. The results were reported in combined form with no note on sex specific differences.

Any other information on results incl. tables

Table 1: Number of animals with intact skin dead and the time range within which mortality occurred. 

Dose
(g/kg
bw)

Mortality (# dead/total)

Time range of deaths (day)

Male

Female

Combined

1.0

 

 

 0/2 

 

1.5

 

 

 1/2

2.0

 

 

 2/2

     8

 Table 2: Number of animals with abraded skin dead and time range within which mortality occurred. 

Dose
(g/kg
bw)

Mortality (# dead/total)

Time range of deaths (day)

Male

Female

Combined

1.0

 

 

0/2 

 

1.5

 

 

    0/2

 2 and 5

2.0

 

 

2/2 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rabbit dermal LD50 of Alfol 12 was between 1500 and 2000 mg/kg. All rabbits showed irritation of the application site immediately following exposure. Some prostration was observed in animals at the higher dose levels. Necropsy findings showed no treatment related lesions.