1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72hrs

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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.