Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles, acceptable for assessment. Study considered valid although result reporting is limited.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: List VII.
Author:
Smyth H F, Carpenter C P, Weil C S, Pozzani U C, Striegel J A, Nycum J S
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 30(5): 470-476

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: other: Smyth et al, 1962
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
icosanol (mixed isomers)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
- Source: no data
- Weight at study initiation: 2.5 -3.5 kg
- Group size: 4
- Controls: no



Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- Area covered: entire trunk

No. of animals per sex per dose:
4

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw

Any other information on results incl. tables

Results were not reported in detail. The LD50 was >20 ml/kg. (>16,800 mg/kg using the density of 0.84 g/cm3 reported in chapter 2.3). No further 

details available.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 value of >20ml/kg is reported in a study which even though lacking in detail is deemed reliable and equivalent to guideline.