Fatty acids, C18-unsatd., mono- and diesters with neopentylglycol and di-and triesters with trimethylolpropane

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:

06 June - 23 June 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (only few details on the test substance given)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of details on test substance

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, triesters with trimethylolpropane

EC Number:

293-037-9

EC Name:

Fatty acids, C16-18, triesters with trimethylolpropane

Cas Number:

91050-90-7

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: solid, white
- Analytical purity: not reported

Test animals

Species:

rabbit

Strain:

other: Kleinrusse, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.4 kg (mean)
- Housing: individually in rabbit-battery
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimatisation: approx. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48, 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm²

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: very slight erythema (grade 1) was seen at 24 and 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: very slight erythema (grade 1) was seen at 24h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: very slight erythema (grade 1) was seen at 24 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: No edema observed

Irritant / corrosive response data:

All 3 animals displayed very slight erythema at reading time point 24 h; in one case (animal 1), erythema remained up to 48 h. The finding was fully reversible for all 3 animals with 48 to 72 h. No edema was seen.

Any other information on results incl. tables

Table 1: Erythema score

Animal Number	1 h	1 day	2 days	3 days
1	0	1	1	0
2	0	1	0	0
3	0	1	0	0

 

Table 2: Edema Score

Animal Number	1 h	1 day	2 days	3 days
1	0	0	0	0
2	0	0	0	0
3	0	0	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