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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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: Comparable to guideline study with acceptable restrictions Occlusive dressing, 48h reading is missing, only 72h observation time, no individual scores reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing, 48h reading is missing, only 72h observation time
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): Coco alkyldimethyl betaines, Commercial name used, equivalent to CAS 68424-94-2
- Analytical purity: 16% solids
- Lot/batch No.: 26R-259
- Other: pH 7.0

Test animals

Species:
rabbit
Strain:
other: albino, not further specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded, respectivley
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): 16%


Duration of treatment / exposure:
24h
Observation period:
24 and 72h
Number of animals:
3, non-abraded and additionally abraded on the posterior of the clipped area
Details on study design:
TEST SITE
- Area of exposure: 2x2, unit not specified
- % coverage: 10%
- Type of wrap if used: Webril patches and the entire experimental area sealed with Blenderm Surgical Tape

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: no individual scores reported
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: no individual scores reported
Irritant / corrosive response data:
The scores of the abraded skin areas were the same than for the non-abraded sites.

Any other information on results incl. tables

Coco alkyldimethyl betaines when applied as 16% solids solution to rabbit skin for 24h show only slight irritating potential after 24h that was fully reversible within 72h and has therefore not to be classified according to the criteria of EU Directive 67/548/EEC and the criteria of Regulation (EC) No 1272/2008.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information