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: guideline comparable to OECD 402

Data source

Reference
Reference Type:
publication
Title:
Contribution à l'étude toxicologique de l'alcool n-heptylique primaire,
Author:
R. Truhaut
Year:
1974
Bibliographic source:
Archive des maladies professionelles, de medecine du travail. T35, No 4-5, Avril-Mai (p 501-509)
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Draize et al., J pharmacol exp thera, 19477, 82, 377-390.
GLP compliance:
no
Test type:
other: Draize et al 1944
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: n-heptanol-1
Cas No. 111-70-6
Purity>97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits were shaved on both the left and right side and also on the back, The skin exposure surface was therefore estimated between 200 cm2 to 350-400 cm2.

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
exposure surface= 250 to 350-400 cm2.
Duration of exposure:
2 weeks
Doses:
40 ml (1.3 g/kg) and 50 ml (2.7 g/kg)
No. of animals per sex per dose:
6 animals/dose
Control animals:
no
Details on study design:
50 ml of test item was administered on the skin surface. Animals were shaved on the back and the left and right sides. The dose-levels of 25 ml (20.5 g) , 40 ml ( 32.8g) and 50 ml (41.0g) were administrated by the cutaneous route. Half of the animals were sacrificed 2 weeks after the fisrt exposure and and the other half 6 weeks after. Major organs were sampled for histopathlogical examination.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
25 ml (20.5 g equivalent 7.32 g/kg): no absorption, no mortality
40 ml(32.8g equivalent 11.7 g/kg): 1.3 g/kg interna dose: 2/6 dead animals
50 ml (41g equivalent 14.6 g/kg) : 2.7 g/kg internal dose: 4/6 dead animals.
Clinical signs:
At the absorbed dose-levels of 1.3 and 2.7 g/kg,tThe skin presented severe escars and sometimes suppurative lesions.
Body weight:
At the absorbed dose levels of 1.3 and 2.7 g/kg, the body weight of the exposed animals were decreased and the food consmption was normal.
Gross pathology:
The results from histopathological examination revealed no alteration of the lung, the heart, liver, kidney, testes, pancreas and spleen. The brain presented spongiosis which was more severe in animals after 6 weeks exposure. The skin presented severe lesions of the derm with deep inflamatory infiltation.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 of n-heptanol 1 is higher than 2000 mg/kg
Executive summary:

The acute dermal toxicity of n-heptanol was evaluated in rabbits according to a comparable draize method. The test item was applied to the skin of rabbits (6 animals/dose) at the dose-levels of 20.5, 32.8 and 41.0 g/ animal for 24 hours. Animals were then observed during 14 days for mortality, clinical signs, effects on body weight. Half of the rats were necropsied after 2 weeks and the other half after 6 weeks. 2/6 animals died at the dose-level of 32.8 g/animal (approx 11.7 g/kg) and 4/6 animals died at 2.7 g/animal (equivalent 14.6 g/kg). Lesions of the skin (caustic) and the brain were recorded at histopathological examination.

The LD 50 by dermal route was higher than 2 g/kg.