Propionaldehyde, reaction product with formaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 17 March 2010 to 18 August 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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:

Propionaldehyde, reaction products with formaldehyde

EC Number:

701-281-9

Molecular formula:

C5H10O3

IUPAC Name:

Propionaldehyde, reaction products with formaldehyde

Details on test material:

- Name of test material: Propionaldehyde, reaction products with formaldehyde (EC 701-281-9) was former registered with identifier 3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde (CAS 18516-18-2)
- Lot/batch No.: CH 138067/001 as cited in report freeze-dried for analytical purpose
- 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 or test system 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:

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:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg.
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.

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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the dressings, the tapes with the patches and the collars were removed.
- Time after start of exposure: The duration of the exposure was 4 hours.

OBSERVATION TIME POINTS
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.

SCORING SYSTEM:
- 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all 3 animals

Time point:

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:

GHS criteria not met

Remarks:

EU GHS

Conclusions:

Based on the mean scores calculated from the individual examinations performed 24, 48 and 72 h p.a. and referring to Regulation (EC) No 1272/2008 the test substance does not require classification for skin irritation.

Executive summary:

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 and investigations were performed in accordance with the OECD Guideline 404 and the Council Regulation (EC) No 440/2008, Method B.4. and in accordance with GLP requirements.0.5 g test substance, 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 on body weights were performed at the start and at the termination of the test. General signs of toxicity were checked once daily and skin examinations were done 1, 24, 48 and 72 h after patch removal (p.a.).

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

Skin examinations

·      Erythema/Eschar: Not observed at any observation point.

·      Oedema: Not observed at any observation point.

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 Regulation (EC) No 127272008 the test substance does not require classification for skin irritation.