5-[(2-hydroxyethyl)amino]-o-cresol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 28 March 1991 to 21 June 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-[(2-hydroxyethyl)amino]-o-cresol

EC Number:

259-583-7

EC Name:

5-[(2-hydroxyethyl)amino]-o-cresol

Cas Number:

55302-96-0

Molecular formula:

C9H13NO2

IUPAC Name:

5-[(2-hydroxyethyl)amino]-2-methylphenol

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Analytical purity: 99%
- Lot/batch No.: OP 169/2
- Description: brown fine powder
- Trade name: IMEXINE OAG

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV specialized breeding establishment (Les Hautes Noës, Saint mars d'Egrenne, 61350 PASSAIS LA CONCEPTION, FRANCE) .
- Age at study initiation: no data
- Weight at study initiation: between 1 .5 kg and 2 .5 kg
- Housing: Animals were kept in cages of standard size . Excreta were eliminated by unrolling plastified brown paper which was placed under the cages .
- Diet: ad libitum to UAR 112 foodstuff (analytical certificate is provided in the study report).
- Water (e.g. ad libitum): ad libitum to softened tap drinking water in polycarbonate feeder bottles with a stainless steel teat . A water sample was taken every three month and sent to the Department of Veterinary Services, 216, rue Louis Mallet, 18014 BOURGES Cedex, FRANCE for analysis (analytical certificate is provided in the study report).
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 45-65
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 21 March 1991 To: 31 March 1991

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

application site moistened with 0 .5 ml of paraffin oil in order to ensure a good contact between the skin and the test item

Controls:

other: The non-treated flank of each animal served as a control

Amount / concentration applied:

0 .5 g of the test item was applied to the right flank of each animal. The non-treated flank of each animal served as a control.

Duration of treatment / exposure:

4 hours

Observation period:

Approximately 1 hour, then 24, 48 and 72 hours after removal of the dressing and of the test item. Observation could be continued until Day 8 and Day 15 if signs of irritation persisted at 72 hours.

Number of animals:

3 females

Details on study design:

TEST SITE
- Preparation: 24 hours before administration, the dorsal region of each animal was carrefully shaved over two symmetrical zones, measuring at least 14 cm x 5 cm, in relation to the vertebral axis, using an AESCULAP FAVORITA II GT 104 electric trimmer. Any animal with damaged skin was eliminated from the study at the time of application. The left flank of each of the animals was left intact.
- Area of exposure: approximately 6 cm2
- Application: the test item was applied to the right flank of each of the animals. The test item was deposited on a gauze square of approximately 6 cm2 . The side of the gauze in contact with the compound was applied to the skin. The application site was moistened with 0 .5 ml of paraffin oil to ensure a good contact between the skin and the test item. The non-treated flank of each animal served as a control.
- Type of wrap if used: The gauze square was protected by a swab held in place with a URGOPORE microporous and non-allergic non-occlusive dressing, and the whole being held in place by coalescent elastic and cohesive hypoallergenic tape COHEVET . Dressings were held in place for 4 hours after application .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour, 24, 48 and 72 hours after the end of the exposure period, extended to days 8 and 15 if signs of irritation persisted at 72hours.

SCORING SYSTEM:

Erythema and Scab Formation
No erythema ...................................................................................................................................0
Slight erythema (scarcely perceptible) ...........................................................................................1
Clearly visible erythema ..................................................................................................................2
Moderate to marked erythema ........................................................................................................3
Severe erythema (reddish purple) with formation of slight eschares (deep lesions) ...................4

Oedema Formation
No oedema ..............................................................................................................................0
Very slight oedema (scarcely perceptible)..............................................................................1
Slight oedema (contours well defined, visible swelling) .........................................................2
Moderate oedema (thickness approximateiy 1 mm) ................................................................3
Severe oedema (thickness more than 1 mm and area greater than that of application) .........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The cutaneous application of the test item did not cause any cutaneous irritation reaction in all animals of the study.
The mean indices per rabbit, for the three times together were:
Erythema and edema : 0 in all animals.

Other effects:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.

Executive summary:

This GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to OECD Guideline 404 (dated May 12, 1981).

Material and methods

0.5 g of the solid test material were applied under semi-occlusive dressing during 4 hours, on a shaved skin area (right flank) of 3 female rabbits. The left flank served as a control. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after the removal of the dressing.

Results

No dermal lesions were observed in any animal at any of the observation time points. The individual mean scores (24, 48 and 72 hours) of all three animals for erythema and edema were both: 0.0, 0.0 and 0.0.

Conclusion

Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.