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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Not specified if conducted to GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Polyol TP30
Trimethylolpropane, ethoxylated, molar ratio 1 :3
purity: > 99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckmsaters, Henham, hertfordshire, England
- Age at study initiation: 12 - 13 weeks
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
30 minutes after removal of the patch and on days 2,3 and 4.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Shorn Skin, 10 cm square
- Type of wrap if used: Elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water



SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: animal #3: score 1 ca. 30 min. after removal of the dressing
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
Not reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results of the study do not trigger classification for skin irritation according to the CLP Regulation.
Executive summary:

The skin irritation of Polyol TP30 (propylidynetrimethanol, ethoxylated) was investigated in a rabbit study (OECD 404). Application of 0.5 mL of the test material for four hours under semi-occlusive conditions to the shorn skin of three rabbits caused minimal transient irritation in one animal. The results of the study do not trigger classification for skin irritation according to the CLP Regulation.