Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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: see 'Remark'
Remarks:
Annex XI of Regulation 1907/2006 and the REACH Guidance (R 6.2) permits the grouping of chemicals (chemicals categorisation). Barratt and Illing (2007, revised 2009a; 2009b, see attachments in section 13 of IUCLID data set) set out justification for an initial grouping of the polyols (oligomers and polymers) using a named core substance, with varying numbers of attached propoxy groups (or propoxy and ethoxy groups). The properties of the core substance and the repeating unit should be reflected in the polyols. The repeating unit is essentially non-toxic. If there are toxic properties associated with a core substance, these properties should reduce with increasing numbers of repeating units (i.e. increasing molecular weight).If both the core substance and the repeating unit are non-toxic, it can be anticipated that there will be no toxicity in the polyol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Principles of method if other than guideline:
fixed dose procedure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nicols Rabbitry, Lumberton, Texas

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn dorsal skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with mild soap and water
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
4
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:The topical response at the site of application was evaluated after patch removal. Animals were observed frequently during exposure and for the following two weeks for signs of toxicity.
Bodyweights were recorded on the day of dosing, thereafter and on days 7 and 14. At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No death
Clinical signs:
No signs of systemic toxicity observed
Body weight:
All rabbits regained pre-treatment weight within 1 week post  treatment.
Gross pathology:
Slight to moderate petechial hemorrhages were observed  in the subcutaneous fat and fascia at the application sites. Underlying  muscle was not involved. The skin was viable and intact.

Applicant's summary and conclusion

Conclusions:
The dermal LD 50 for the test substance is >5000 mg/kg bw