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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lactic acid
EC Number:
200-018-0
EC Name:
Lactic acid
Cas Number:
50-21-5
Molecular formula:
C3H6O3
IUPAC Name:
2-hydroxypropanoic acid
Details on test material:
- Name of test material (as cited in study report): L(+) lactic acid 80%, diluted with water

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Approx 24 hours after clipping the skin were abraided sufficiently deep to penetrate the stratum corneum but not the dermis. After test substance application, the trunk of each animal was wrapped.
Duration of exposure:
After a 24 hour exposure period, each binder was removed and the test site of the animal was wiped to remove the remaining test article.
Doses:
2 g/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
Animals were observed for mortality and abnormal clinical signs hourly after dosing on day 0. Observations for mortality and abnormal clinical signs were done twice daily thereafter during the duration of the study (14 days). On day 14 all animals were rendered unconscious and were exsanguinated prior to gross necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived the 14-days duration of the study.
Clinical signs:
other: No abnormal clinical signs were observed during the study. Severe erythema and severe oedema were observed at the test sites of all animals after removal on day 1. Erythema decreased in severity for 3 animals on day 12 or 14, and was not observed for one
Gross pathology:
Multiple depressions in the treated skin were observed during necropsy of one of the same males, of 2 other males , and of one other female. A dark red focus was observed on the lung of one male. No other abnormalities were observed during necropsy of all males and 4 females, and no abnormalities were observed during necropsy of one female.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)