Bis(16-methylheptadecyl) malate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no analytical purity and clinical signs reported; environmental condition (temperature range) differs from the temperature recommended in the appropriate OECD guideline

GLP compliance:

no

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): diisostearyl malate
- Physical state: colourless liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: adult animals
- Weight at study initiation: 2200 - 3500 g
- Housing: the animals were housed individually in polystyrene cages.
- Diet: granulated diet 112 C (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 3 min and 4 h

Observation period:

7 days
Reading time points: 1, 24, 48 and 72 h and 4 days

Number of animals:

3 males (main test)
1 male (initial test)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on one site of the dorsal/flank area
- Type of wrap if used: The test item was introduced under a patch which was secured in position with a hypoallergenic medical plaster.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicablereversibility: not applicable

Irritant / corrosive response data:

In an initial test slight erythema formation (grade 1) was noted in one animal 1 h after patch removal and remained 48 h after patch removal and was fully reversible within 72 h. No edema formation was observed. Slight erythema formation (grade 1) was noted in 3/3 animals 1 h after patch removal and remained in all animals 24 h after patch removal. Erythema formation was fully reversible within 48 h in 2/3 animals and 4 days in 1/3 animals. No edema formation was recorded in any animal.

Any other information on results incl. tables

Table 1: Summary of individual skin irritation after 3 min and 4 h exposure in one rabbit (initial test)

Observation time	Rabbit no.
	1
	Erythema	Edema
1 h	1	0
24 h	1	0
48 h	1	0
72 h	0	0
Mean value 24+48+72 h	0.67	0

Table 2: Summary of individual skin irritation scores after 4 h exposure (main test)

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	0	1	0	1	0
24 h	1	0	1	0	1	0
48 h	1	0	0	0	0	0
72 h	1	0	0	0	0	0
Mean value 24+48+72 h	1	0	0.33	0	0.33	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