Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is well described and performed according to OECD testing guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, FRANCE.
- Weight at study initiation: average weight 2.5 ± 0.1 kg of the 3 males at the start of the experiment .
- Housing: Upon receipt, the animals received a preventive treatment for coccidiosis by administration of a Mucoxid (R) solution at the dose of 137.5 mg/kg/d at a volume of 10 ml/kg (Véda-Cogla, 45140 Saint Jean de la Ruelle, FRANCE). Observation was performed at the time of delivery of the animals and daily during the acclimatisation period. Animals were housed individually in cages of standard size. These cages were placed in an air-conditioned (20 ± 3°C) animal house kept at between 50 ± 20 % relative humidity. These parameters are recorded in each room. Non recycled air is filtered by absolute filters. The artificial day/night cycle was 12 hours light and 12 hours darkness.
- Diet: "Rabbits sustenance 112 C" from U.A.R. 91360 VILLEMOISSON SUR ORGE, was available ad libitum. A certificate of analysis (including the main contaminants) is provided by the supplier for every batch.
- Water: free access to tap water filtered by 0.22 micron filter membrane. Drinking water was available ad libitum in bottles. A specimen of water is regularly sent to a laboratory for bacteriological and chemical analysis (Laboratoire Municipal et Régional de Rouen, 76000 ROUEN, FRANCE.
- Acclimation period:For at least 5 days before the treatment, in the area where the experiment took place.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
24 hours before the test, the flanks of each rabbit were partially clipped. Only animals showing no obvious signs of irritation were used for the experiment. 0.5 mL of the substance (as supplied) was added on an hydrophilic gauze patch (6 cm2) applied to the skin of the right flank region. The left flank did not receive any substance and served as a control.
The substance and the gauze patch were maintained in contact with the skin by a semi-occlusive and aerated hypoallergenic adhesive dressing attached with a gauze bandage. The 3 animals were fitted with this patch for 4 hours and then the dressing was removed and the animals placed back into their individual cages. No residual test substance was observed after its removal.
Duration of treatment / exposure:
4 hour
Observation period:
at 1h and then 24h, 48h and 72h after the patch removal. And then daily until reversibility of the reactions.
Number of animals:
3
Details on study design:
The test item was applied once on the 3 animals for a duration of exposure of 4 hour under a semi-occlusive dressing. The cutaneous reactions were evaluated for Erythema and Oedema formation and their reversibility.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
2
Max. score:
4
Remarks on result:
other: clearly visible erythema in 3 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2.7
Max. score:
4
Remarks on result:
other: moderate to severe erythema in the 3 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Remarks on result:
other: moderate to severe erythema in the 3 animals and greyish colouration in 2 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: moderate to severe erythema in the 2 animals. A persistant crust persist at the end of the observation.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
3.3
Max. score:
4
Remarks on result:
other: slight in 1 animal and severe in 2 animal oedema
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
4
Remarks on result:
other: very slight oedema in 2 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Observations on Erythema :
1 hour after the patch removal : clearly visible erythema in 3 animals.
At 24h and 48h : moderate to severe erythema in 3 animals and greyish colouration of the skin
At 72h : erythema disappeared in 1 animal and in the two others is moderate to severe.
The erythema became very slight between day 5 and 12 and the greyish colouration of the skin turned to a crust between day 13 and 15.

Observations on Oedema :
1 hour after the patch removal : slight oedema in 1 animal and severe in 2 animals
At 24 h : very slight oedeme in 2 animals
At 48h : no oedema observed

Any other information on results incl. tables

Mean value calculated from the scores recorded after 24h, 48h and 72h for each animal

 

ANIMAL

Maximum score per site

1

2

3

ERYTHEMA

2.7

3.0

3.0

3 for 6 days

OEDEMA

0.0

0.3

0.3

1 after 24 hours

Score for each animal at each time of observation

OBSERVATION Hour/Day

ERYTHEMA

OEDEMA

Animal 1

Animal 2

Animal 3

Animal 1

Animal 2

Animal 3

1h

2

2

2

2

4

4

24h

2

3

3

0

1

1

48h

3

3/G

3/G

0

0

0

72h

3

3/G

3/G

0

0

0

5d

2

3/G

2/G

0

0

0

6d

2

3/G

2/G

0

0

0

7d

1/D

3/D/G

2/D/G

0

0

0

8d

0/D

2/D/G

1/D/G

0

0

0

9d

0/D

2/D/G

1/D/G

0

0

0

10d

0/D

1/D/G

1/D/G

0

0

0

11d

0

1/D/G

1/D/G

0

0

0

12d

-

1/D/G

1/D/G

-

0

0

13d

-

0/A

0/A

-

0

0

14d

-

0/A

0/A

-

0

0

G = Grey coloration of the skin

G = Grey coloration of the skin

D = Desquamation

A = crust

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results of this test, the substance is considered as irritant to the skin in rabbits.
Executive summary:

Any irritant property and/or degree of corrosion of the substance Glyoxalate d'Ethyle (HF 7846) was evaluated in the rabbits following a single semi-occluded application to intact skin in accordance with the method B4 of Commission Directive 84/449/CEE and following the GLP.

3 animals were used for this study.

0.5 mL of HF 7846 was applied on the skin via an absorbent gauze. Adjacent surfaces of untreated skin served as a control for the trial. Semi-occlusive dressings held the test item in place for 4 hours on the skin of 3 animals. After patch removal, the cutaneous reactions were evaluated at different times (1h, 24, 48h and 72h) for Erythema and Oedema formation and their reversibility (until day 15).

At 24h and 48h severe to moderate erythema was observed in at least 2 animals and a greyish coloration was also noted for 2 animals.

The reactions were completely reversible in one week in one animal or remained moderate for 14 days in 2 animals. The greyish coloration was replaced by a persistent crust between day 13 and the end of the observation.

A slight oedema was observed in 1 animal and a severe oedema in 2 animals after 1 hour of patch removal. But this oedema disapears at 48h in all animals.

According to the results of this test, the substance is classified as irritant catg. 2, according to the CLP Regulation No. 1272/2008.