[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-05-16 to 2007-06-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted April 24, 2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

April 29, 2004

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol

Molecular formula:

not applicable (UVCB)

IUPAC Name:

Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 07SK021
- Description: Liquid, dark brownish
- Expiration date of the lot/batch: n.a.
- Purity test date: 94%
- Expiry date: March 2009

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5° C), light protected

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
Postbus 6174, NL-5960 AD Horst / The Netherlands

- Age at study initiation: one male12 weeks; two females 13 weeks
- Weight at Day1 of treatment: females 2044 g and 2500 g, male 2373 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after exposure (removal of the dressing, gauze patch and test item).

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days after treatment

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

other: scaling

Basis:

mean

Time point:

other: 72 hour reading up to 10 day reading

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Well-defined erythema was noted at the application site of all animals between 1 hour and 72 hours after treatment. The severity of the erythema decreased to very slight at the 7-day observation and was no longer evident 10 days after treatment. Very slight oedema was recorded in all animals between 1 hour and 72 hours after treatment. All animals showed scaling from 72 hours up to 10 days after treatment and inelastic and dry skin from 72 hours up to 7 days after treatment. All these skin reactions were reversible and no longer evident 14 days after treatment, the end of the observation period for all animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not skin irritant according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 Dec. 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC

Conclusions:

not skin irritant

Executive summary:

In order to evaluate the skin irritating property of Dodicor V 5654, an OECD TG 404 GLP conform study in rabits is provided.

Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.5 mL of Dodicor V 5654 was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time. No staining produced by the test item of the treated skin was observed. The body weights of all rabbits were considered to be within the normal range of variability.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. For each of the three animals the mean erythema/eschar score was 2.00 and the mean oedema score was 1.00. Well-defined erythema was noted at the application site of all animals between 1 hour and 72 hours after treatment. The severity of the erythema decreased to very slight at the 7-day observation and was no longer evident 10 days after treatment. Very slight oedema was recorded in all animals between 1 hour and 72 hours after treatment. All animals showed scaling from 72 hours up to 10 days after treatment and inelastic and dry skin from 72 hours up to 7 days after treatment. All these skin reactions were reversible and no longer evident 14 days after treatment, the end of the observation period for all animals.

Based on the results of this study, Dodicor V 5654 is not a skin irritant.