2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

16. Dec. - 23. Dec 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. (Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

(Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)

GLP compliance:

yes (incl. QA statement)

Remarks:

Safepharm Laboratories Limited, Derby, UK

Test material

Test material information

Constituent 1

Reference substance name:

131459-39-7

Cas Number:

131459-39-7

IUPAC Name:

131459-39-7

Details on test material:

- Physical state: straw colored liquid
- Analytical purity: not given, responsibility of the sponsor
- Storage condition of test material: room temperature 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., Moston, Sandbach, Chesire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.74 - 3.07 kg
- Housing: individual housing in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 50 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

7 days
reading time points: 1, 24, 48 and 72 hours and 7 days

Number of animals:

3 (2 males and 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5cm on the back of each rabbit
- Type of wrap if used: cotton gauze patch secured with a strip of surical adhesive tape and wrapped with an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours

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 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: loss of skin elasticity at 72 hours and desquamation after 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: desquamation after 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites at the 24 and 48-hour observations and at two treated skin sites at the 72-hour observation. Very slight edema was noted at all treated skin sites at the 24-hour observation and persisted at two treated skin site at the 48 and 72-hour observations.

Other effects:

Loss of skin elasticity was noted at one treated skin site at the 72-hour observation. Slight desquamation was noted at two treated skin sites at the 7-day observation.

Any other information on results incl. tables

Table 1. Results of skin irritation study.
Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0	0	0
24 h	1	1	1	1	1	1
48 h	1	0	1	1	1	1
72 h	0	0	1	1	1	1
7 days	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0,67	0,33	1,00	1,00	1,00	1,00
Mean value 24 + 48 + 72 h all animals	0,89	0,78

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified