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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
secondary source
Title:
Toxicology Update: Triethylene glycol.
Author:
Ballantyne, B., Snellings, W.M.
Year:
2007
Bibliographic source:
J. Appl. Toxicol. 27, 291 - 299

Materials and methods

Principles of method if other than guideline:
Six New Zealand White rabbits were dosed with 0.5 mL of test material under an occlusive dressing for a period of 4 hours. After the exposure period skin reactions were scored via the method of Draize.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
Male and female animals are dosed with 0.5 mL. The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material is applied to each of 6 rabbits, which are restrained for the 4 h contact period. Excess sample is removed after contact. Skin reaction is scored by the method of Draize at 1 hour, 1 day, 2 days, 3 days and 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema or eschar formation, no edema formation. Other irritation or effects: none.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met