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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: 2d: Test procedure in accordance with national standard methods with acceptable restrictions.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register, 1978, 43, 37355-6
Principles of method if other than guideline:
Single exposure for 24 h to single dose of 5000 mg/kg undiluted. Observation period 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
EDA, EO + PO
Lot TB11170-841
Based on producers products specs information from the producer (not available in the report) the test material was 70–90% PO and 10–30% EO and has a Molecular Mass of (average Mn = 280 g/mol)

Test animals

Species:
rabbit
Sex:
male/female

Administration / exposure

Vehicle:
other: undiluted
Doses:
5000 mg/kg single dose
No. of animals per sex per dose:
2

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

Any other information on results incl. tables

All rabbits survived and no signs of systemic toxicity were  observed following application of the test material. No redness swelling of necrosis was observed on the treatment site when the sleeves were removed. Pre treatment weight was  regained 1 week post-treatment. Upon gross pathological examination, mild petechial hemorrhages were observed in the  subcutaneous fat and fascia at applications sites.  Underlying muscle was not involved. The skin was viable and  intact. No other lesions attributable to treatment were  observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 of >5000 mg/kg: no EU classification for acute oral toxicity.