Methyl (R)-amino(4-hydroxyphenyl)acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

end on 9-APR-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl (R)-amino(4-hydroxyphenyl)acetate

EC Number:

253-657-2

EC Name:

Methyl (R)-amino(4-hydroxyphenyl)acetate

Cas Number:

37763-23-8

Molecular formula:

C9H11NO3

IUPAC Name:

methyl (2R)-2-amino-2-(4-hydroxyphenyl)acetate

Details on test material:

- Name of test material (as cited in study report): FGHM
- Molecular formula (if other than submission substance): C9H11NO3
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: stability in water not indicated
- Storage condition of test material: in refrigerator in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 1564 - 1740 g
- Housing: individually in labelled cages with perforated floor
- Diet: standard laboratory rabbit diet, approx. 100 g per day. In addition, hay was provided once a week.
- Water: free access to tap water diluted with decalcified water.
- Acclimation period: at least 5 days before start of the treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50%
- Air changes: approx. 15 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: data not available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

moistened

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: shaved on 10 x 15 cm2
- % coverage: data not available
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with a tissue moistened with tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean vamue (24, 48, 72h)

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean value (24, 48, 72h)

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin irritation/corrosion was caused by FGHM after 4 hours of exposure.
All scores of erythema and edema were "0" at 1, 24, 48 and 72h.

Other effects:

No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

HPGM (FGHM) is not irritating to the skin in the rabbit.

Executive summary:

In a primary dermal irritation study (OECD 404, GLP), 8 week old New Zealand White rabbits (3 males) were dermally exposed to 0.5 g of HPGM (FGHM) moistened with water for 4 hours under semi-occlusive conditions. Animals then were observed for 72 hours. Irritation was scored by the method of OECD guideline.

 

No skin irritation/corrosion was caused by FGHM after 4 hours of exposure.

All scores of erythema and edema were "0" at 1, 24, 48 and 72h.

 

According to EC criteria for classification of dangerous substances (DSD directive and CLP regulation), HPGM (FGHM) is not classified as irritating to the skin.