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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:
17 March 2010 to 18 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

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): "3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde"
- Molecular formula (if other than submission substance): C5H10O3
- Physical state: Colourless, high viscous
- Composition of test material, percentage of components: ~ 82 % Dimethylpropanale, ~ 10 % Hydroxyethanesulfonic acid, Na-salt (CAS No.: 870-72-4), ~ 6 % water, ~ 2 % Potassiumformiate (CAS No.: 590-29-4)
- Lot/batch No.: CH 138067/001
- Expiration date of the lot/batch: 30 November 2010
- Stability under test conditions: Min. 1 year
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Species and strain: Rabbits, New Zealand White.
Supplier: Charles River Deutschland GmbH, D-88353 Kisslegg.
Number and sex: 3 females.
Body weight (at the start and at the termination of the study):
Animal No. 1: 2.1 kg and 2.3 kg.
Animal No. 2: 2.5 kg and 2.5 kg.
Animal No. 3: 2.4 kg and 2.5 kg.

Hygiene: Optimal hygienic conditions.
Room number: EI1-8.
Room temperature: Ranges from 19.32 to 20.83 °C.
Relative humidity: Ranges from 44.05 to 57.72 %.
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 65 cm x 65 cm bottom area, 50 cm height.
Feed: Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany.
Water: Tap water from an automatic watering system, ad libitum.
Identification: Labelling with felt-tipped pen on a pinna and cage labels.
Acclimatisation: 7 days (animal No. 1) and 14 days (animal Nos. 2 and 3)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g per animal
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 females
Details on study design:
Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. An electric hair clipper, Aesculap GH 204 with a 1 mm cutterhead, was used.
The test sites were median on the dorsal thoracal region.
Samples with approximately 0.5 g of the test substance were moistened with 1.0 mL deionised water and were placed on gauze patches1) in a size of about 2.5 cm x 2.5 cm and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes2). The application sites were covered semi-occlusively by a dressing3).
Access by the animals to the application sites was prevented by a plastic collar.
The duration of the exposure was 4 hours.
At the end of the exposure period the dressings, the tapes with the patches and the collars were removed.
1) Pur Zellin-Tupfer, obtained by Fa. Hartmann , A-2355 Wiener Neudorf.
2) "Blenderm ®" surgical tape, hypoallergenic, 3M, Medical Products Division, St. Paul, MN 551444, USA.
3) Self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg.

The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hours after patch removal.
No further examinations were performed thereafter.
The surrounding of the administration area, i.e. the untreated skin, served as a negative control.
The skin was examined using a cold light source KL 1500 electronic.
Dermal irritation was described and recorded according to the scoring scheme for acute dermal irritation/corrosion tests.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All areas treated with the test substance and all control areas were normal before the application.
Erythema/eschar: Not observed at any observation point.
Oedema: Not observed at any observation point.
Other effects:
None

Any other information on results incl. tables

 

 

Mean Scores for Animal No.:

 

1

2

3

Erythema / Eschar:

0.0

0.0

0.0

Oedema:

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the mean scores calculated from the individual examinations performed 24, 48 and 72 h p.a. and referring to Commission Directive 2001/59/EC the test substance does not require classification for skin irritation.
Executive summary:

Aim of the study

The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD Guideline 404 and theCouncil Regulation (EC) No 440/2008, Method B.4.

Administration of the test substance

0.5 g"3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde", moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing.

The duration of the exposure was 4 hours.

First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.

Investigations

·      Body weights: at the start and at the termination of the test.

·      General signs of toxicity: once daily.

·      Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).

Results

General signs of toxicity

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations

·      Erythema/Eschar: Not observed atany observation point.

·      Oedema: Not observed atany observation point.

Conclusion

The following mean scores were calculated for each animal from the examinations 24 h,
48 h and 72 h p.a.:

 

 

Mean Scores for Animal No.:

 

1

2

3

Erythema / Eschar

0.0

0.0

0.0

Oedema

0.0

0.0

0.0

 

 

 

According to Commission Directive 2001/59/EC"3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde"does not require classification for skin irritation.