Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP, no guideline, as study is older than the guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Areas of the back of rabbits were shaved to comprise about 30% of the body surface., 24 hours prior to treatment . Test material was applied at different concentrations in a undiluted form. Semi-occlusive wrapping was performed for 24 hours , then the bandage was removed skin was washed and reactions were observed daily including mortality
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
All animals kept for 5 days under observation and clinical checks. Animals were housed on macrolon cages and fed standard laboratory diet (pellets) and water ad liobitum., except during a 16-hour period prior to treatment.
Initial and final body weights were recorded, moritalities and clinical signs.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
In order to prevent close contact og th mouthof the animals with the covered dermal site, each animal received a plastic collar to prevent such licking
Duration of exposure:
24 hours
Doses:
300, 1000 , 3000 mg/kg body weight
No. of animals per sex per dose:
1 male & 1 fmale rabbit each group
Control animals:
not required
Details on study design:
no data
Statistics:
no statistical analysis was performed

Results and discussion

Preliminary study:
no RF-study performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
300 mg/kg : 0/2
1000 mg/kg: 0/2
3000 mg/kg : 0/2
Clinical signs:
other: no clinical singns were recorded whicxh were treatment elated. At the end of the treatment period, local skin reactions were observed (slight erthema). At necropsy emaciation, pale kidney and pale liver were recorded in one high dose animal (male) which
Gross pathology:
no other gross pathological findings were recorded.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this dermal toxicity test in rabbits the LD 50 was > 3000 mg/kg body weight
Executive summary:

In this dermal toxicity test in rabbits the LD 50 was > 3000 mg/kg body weight