10-Undecenoic acid, monoester with 1,2,3-propanetriol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 - 26 Dec 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No experimental 48 h reading performed, an occlusive dressing was used, the test substance purity was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Apr 2002

Deviations:

yes

Remarks:

no experimental 48 h reading performed, an occlusive dressing was used, the test substance purity was not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): undecylenate de glycerol
- Physical state: white paste
- Analytical purity: no data
- Lot/batch No.: 0512 BL

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: COB.LABO.LAP, Yffiniac, France
- Weight at study initiation: approximately 1.8 kg
- Housing: animals were housed individually in cages (48.7 x 39.5 x 28 cm). During the acclimation period, the animals were subjected to an anticoccidial treatment administered via the drinking water.
- Diet: pellets (Grand Moulins de Paris, Vigala 756), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: the flank
- Type of wrap if used: the test site was covered with an 8-layer hydrophile gauze, which was held in place by a 5-cm Blenderm tape. A 10-cm flexible bandage was wrapped around the trunk, covering the test site, and fixed using adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

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:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: No 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). Only the data on intact skin was considered for evaluation.

Irritant / corrosive response data:

Intact skin:
At the 24-hour reading time point, 2/3 rabbits had well defined erythema (score 2) and 1/3 had slight erythema (score 1). 72 hours after patch removal, the severity of the skin effects was reduced to slight erythema (score 1) in 1/3 animals and had cleared completely in 2/3. Slight edema (score 1) was observed in 2/3 rabbits at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point. No edema was noted in the third animal.

Abraded skin:
At the 24-hour reading time point, 3/3 rabbits had well defined erythema (score 2), which was reduced in severity to slight erythema (score 1) in 1/3 animals and had cleared completely in 2/3 animals by 72 hours after patch removal. Slight edema (score 1) was observed in 2/3 rabbits 24 hour after patch removal. The edema had cleared completely at the 72-hour reading time point.

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
24 h	1	0	2	1	2	1
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	0	1	0	0	0

 

Table 2. Calculation of mean scores

	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	0.67	0	1.67	0.67	1.33	0.67

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified