Fatty acids, C16-18, Bu esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

04 - 07 Jan 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions (analytical purity of test substance was not specified).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test material

Test material information

Constituent 1

Reference substance name:

163961-32-8

Cas Number:

163961-32-8

IUPAC Name:

163961-32-8

Details on test material:

- Name of test material: only trade name given
- Physical state: amber colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended matal cages
- Diet: ad libitum, certified rabbit diet (Code 5322, PMI Nutrition)
- Water: ad libitum
- Acclimation period: at least 5 days


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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 24, 48 and 72 hours

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: cotton gauze patch secured in position with surgical adhesive patch


REMOVAL OF TEST SUBSTANCE
- Washing: with cotton soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritant / corrosive response data:

Well-defined erythema was noted at all treated skin sites one hour after patch removal regressing to very slight erythema at all treated skin sites at the 24 h observation and two treated skin sites at the 48 h observation.
Slight edema was noted at all treated skin sites one hour after patch removal regressing to very slight erythema at all treated skin sites at the 24 h observation. One treated skin site appeared normal at the 48 h observation and the two remaining treated skin sites appeared normal at 72 h.

Any other information on results incl. tables

Erythema Score

Animal Number	24 h	48 h	72 h
1	1	0	0
2	1	1	0
3	1	1	0

 

Edema Score

Animal Number	24 h	48 h	72 h
1	1	0	0
2	1	0	0
3	1	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified