2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June 1995 - 30 June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed to GLP and according to appropriate OECD and EC test guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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:

2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

EC Number:

245-509-0

EC Name:

2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

Cas Number:

23235-61-2

Molecular formula:

C12H26O5

IUPAC Name:

2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): Di-TMP (flakes), Di-Trimethylolpropane
- Physical state: Irregular white crystalline flakes.
- Lot/batch No.: 54001-80
- Storage condition of test material: Kept in a tight-fitting container at room temperature in the dark
- Other: Test article characterisation (purtiy, solubility and stability etc.) was the responsibility of the Sponsor.

Test animals

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mol:Russian stock from Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.1 - 2.5 kg.
- Housing: Animals caged individually in PPO/HIPS (Noryl) cages (floor area 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Ad libitum access to pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted.
- Water (e.g. ad libitum): Ad libitum access to domestic quality drinking water, acidified to pH 2.5 with hydrochloric acid to prevent microbial growth.
- Acclimation period: At least one week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3ºC
- Humidity (%): 55±15%
- Air changes (per hr): 10 air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours darkness.


IN-LIFE DATES: From: 19 June 1995 To: 30 June 1995

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g solid test material moistened using 0.5 mL distilled water was applied to 2.5 x 2.5 cm patches.

Duration of treatment / exposure:

4 hours.

Observation period:

Observations made 1 hour after removal of dressing / test material then 24, 48, and 72 hours after termination of exposure.

Number of animals:

3 female rabbits.

Details on study design:

TEST SITE
- Area of exposure: 2 patches, 2.5 x 2.5 cm on each animal.
- Type of wrap if used: gauze patches secured with a semi-occlusive dressing by means of a 1cm wide adhesive tape and fixed with Scanpor tape,
4.5 cm width, loosely wound round the trunk.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patches removed and the skin was washed with lukewarm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Scoring system used was consistent with system described in OECD test guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation were observed during the observation period.

Other effects:

None

Any other information on results incl. tables

Rabbit No.	Weight kg	Test field	Erythema-Eschar observed at hours*				Individual mean values	Oedema observed at hours*				Individual mean values
			1	24	48	72		1	24	48	72
7697	2.5	L	0	0	0	0	0.00	0	0	0	0	0.00
		R	0	0	0	0		0	0	0	0
7700	2.1	L	0	0	0	0	0.00	0	0	0	0	0.00
		R	0	0	0	0		0	0	0	0
7703	2.2	L	0	0	0	0	0.00	0	0	0	0	0.00
		R	0	0	0	0		0	0	0	0
Mean of rabbits							0.0					0.0

Only the scores from the 3 readings (24, 48, and 72 hours) are included in the calculation of the individual mean values.

* after termination of exposure

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DiTMP was found ot be non-irritating to skin, under the conditions of this study and does not require classfication as a skin irritant according to the CLP Regulation.

Executive summary:

An acute skin irritation study was performed to determine the potential for skin irritation of Di-TMP. The study was conducted to GLP and according to OECD 404 and EC B4 Test Guidelines. No signs of irritation were observed following exposure to the test substance. Di-TMP is not classified as irritating according to CLP.