Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Lack of details on test substance, lack of tabulation of individual scores and occlusive dressing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance, lack of tabulation of individual scores and occlusive dressing
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): triacetin
- Physical state: clear, colourless liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2312.5 g
- Housing: individual housing
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrling GmbH, Bad Salzufen, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: dorsal skin; 2.5 cm x 2.5 cm
- Type of wrap if used: linen patch covered by a plastic foil, fixed by adhesive tapes and acrylastic band.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Only 1 out of 4 tested animals showed a mild erythema 1 h after application. Therefore, a tabulation of the scores was not given.
Other effects:
No other local or systemic effects were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified