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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
Study period:
04/05/1988 - 07/05/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
EC Number:
293-883-9
EC Name:
1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
Cas Number:
91648-24-7
Molecular formula:
C14H24O4
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: approximately 8 to 13 weeks
- Weight at study initiation: 1.9 - 2.8 kg
- Housing: Individually housed in metal cages with perforated floors
- Diet: Ad libitum (SDS Standart Rabbit Diet)
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19°C
- Humidity: 30 - 70%
- Air changes: 19 per hr
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
with an electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: dorso- lumbar region
- Coverage: approximately 10 cm square
- Type of wrap if used: Elastoplast elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, the treatment site was washed using water to remove any residual test substance
OBSERVATION TIME POINTS
Day 1 (approximately 30 minutes after removal of the patches and Days 2 (24hrs),3 (48hrs) and 4 (72 hrs)

SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1mm) 3
Severe oedema (raised more than 1mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72hrs
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Very slight erythema accompanied by very slight oedema was observed in all three animals after removal of the dressings. All reactions had resolved by day 3 or 4 of the study
Other effects:
No adverse local or systemic effects were observed

Any other information on results incl. tables

Dermal reactions

Rabbit Number and Sex

Day

1*

2

3

4

#1 Male

Erythema

1

1

1

0

Oedema

1

1

0

0

#2 Male

Erythema

1

1

1

0

Oedema

1

1

0

0

#3 Male

Erythema

1

1

0

0

Oedema

1

1

0

0

* Approximately 30 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether produced very slight dermal irritation effects. However, the test material does not meet the requirement for classification as an irritant to the skin according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The skin irritation potential of 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether was investigated in a rabbit study (OECD 404). 0.5mL of the test material was applied under semi-occlusive conditions for a 4 hour period to the shorn dorsal of three rabbits. Animals were observed on Day 1 (30 minutes after removal of the patches) and on Days 2, 3 and 4 for oedema and erythema and skin irritation was assessed. Very slight erythema accompanied by very slight oedema was observed in all three animals after removal of the dressings. All reactions had completely resolved Day 3 or 4 of the study. For each animal, the maximum mean score for erythema was 0.67 and for oedema, the maximum mean score was 0.33. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether does not therefore meet the requirement for classification as a skin irritant according to the CLP Regulation.