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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study. Study was conducted in accordance to GLP and OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Propoxylated glycerol mw 300, pure colourless viscous liquid.
Purity: 99.98%, Contains 200 ppm antioxidant.
Polyol 355 UCB
Batch No: 0133759A

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival, Moston, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.40 - 2.79 g

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: none
Controls:
no
Amount / concentration applied:
undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Back of the rabbit, 2.5 cm square
- Type of wrap if used: Surgical adhesive tape and wrapped in an elastic corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize J.H

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 mean
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema (grade 1) was observed in one animal only at the 1 hour observation period. All test sites appeared normal at 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Propoxylated glycerol mw 300 is not a skin irritant according EU criteria following a 4 hour occlusive exposure to rabbit skin.

Classification: not irritating