2-hydroxy-5-octanoylbenzoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 october 1989 to 14 october 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study following OECD and EU guidelines, with minor deviations: no certificate of analysis and housing temperature

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No certificate of analysis, deviation in housing temperature

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

417-790-1

EC Name:

-

Cas Number:

78418-01-6

Molecular formula:

C15H20O4

IUPAC Name:

2-Hydroxy-5-(1-oxooctyl)benzoic acid

Constituent 2

Reference substance name:

MEXORYL SAB

IUPAC Name:

MEXORYL SAB

Details on test material:

- Name of test material (as cited in study report): ER 195
- Physical state: white crystalline powder
- Lot/batch No.: DG6
- 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:

TEST ANIMALS
- Source: David Percival Ltd, Moston, U.K.
- Age at study initiation: approximately 12 weeks to 16 weeks old
- Weight at study initiation: 2.12 - 2.30 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet (Preston Farmers limited, New Leake, U.K.), ad libitum
- Water (e.g. ad libitum): normal drinking water, ad libitum
- Acclimation period: after a minimum acclimatisation period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 62-65
- Air changes (per hr): approximately 15 changes/h
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark

IN-LIFE DATES: From: 11 October 1989 To 14 October 1989

Test system

Type of coverage:

other: elasticated corset

Preparation of test site:

other: clipped dorsal and flank area

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset (Tubigrip)

REMOVAL OF TEST SUBSTANCE
- Gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J. H. scale (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation

Other effects:

No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was regarded as not irritating according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a primary dermal irritation GLP study performed according to OECD guideline 404, three young adult male White New-Zealand rabbits were dermally exposed to 0.5 g of ER 195 in 0.5 mL of distilled water for 4 hours to 6.25 cm² of clipped skin. Animals then were observed for 3 days. Irritation was scored by the method of Draize (1959).

There was no irritant effect at any observation time point. In this study, ER 195 is not a dermal irritant on male rabbits.

Under the test conditions, ER 195 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).