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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
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
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
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.