Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a protocol which is comparable to guideline but it was not compliant with GLP. The study is read across from undecan-1-ol (CAS 112-42-5).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, in tact skin of male/female rabbits.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No detail available.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 1.8-2.5kg

- Housing: individual cages

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: undiluted
Details on dermal exposure:
Test material was applied to intact skin.
Duration of exposure:
24 hours
Doses:
3160, 5010 and 7940 mg/kg
No. of animals per sex per dose:
3160 mg/kg; 1F, 5010mg/kg; 1M, 7940 mg/kg;1M, 1F.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 010 - < 7 940 mg/kg bw
Mortality:
A female rabbit died at 7940mg/kg dose level on day 4.
Clinical signs:
Reduced appetite and activity and lethargy (three to five days in survivors), increasing weakness, collapse and death.
Body weight:
No data.
Gross pathology:
At necropsy there was slight lung congestion, liver discolouration, enlarged gall bladder and slight gastrointestinal inflammation. Surviving animals were sacrificed 14 days after dosing. The viscera appeared normal by macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The rabbit acute dermal LD50 was reported to be > 5010 mg/kg (but <7940 mg/kg). The study was not compliant with GLP. The result is read across from undecan-1-ol (CAS 112-42-5).