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Description of key information

Skin, rabbit: not irritating
Eye, rabbit: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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.
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.
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.
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.
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.
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.

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).

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 - 14 May 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Limited data on animal husbandry, six animals were used, no anasthetics were used, the test substance purity was not specified.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Oct 2012
Deviations:
yes
Remarks:
limited data on animal husbandry, six animals were used, no anasthetics were used, the test substance purity was not specified.
Qualifier:
according to guideline
Guideline:
other: Official method of the French Republic published in 'Journal Officiel' 21 Feb 1982 and 24 Oct 1984
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: COB.LABO.LAP, Yffiniac, France
- Weight at study initiation: approximately 2.1 kg
- Housing: animals were housed individually
- Acclimation period: 3 weeks
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h, and day 4 and 7 (mean values only given for day 7)
Number of animals or in vitro replicates:
6 males
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
One hour after instillation of the test substance, 6/6 rabbits had obvious swelling (chemosis score 2) and 1/6 rabbits had some conjunctivae (score 1). At the 24-hour reading time point, chemosis (score 1-2) was observed in 6/6 animals. The chemosis gradually reduced in severity, persisting in 4/6 at the 48-hour reading time point, in 3/6 at the 72-hour reading time point, and in 1/6 until 4 days after instillation. No conjunctivae was observed in any animal from 24 hours after instillation. No irritation effects were seen on the iris and cornea in any animal at any reading time point. Only mean values were given for Day 7, and it is therefore not possible to determine if the irritation effects had cleared by Day 7.

Table 1. Eye irritation scores

Rabbit #

 

Time

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1 h

0

2

0

0

24 h

0

2

0

0

48 h

0

0

0

0

72 h

4 d

0

0

0

0

0

0

0

0

Average*

0.0

0.67

0.0

0.0

2

 

 

 

 

1 h

0

2

0

0

24 h

0

2

0

0

48 h

0

2

0

0

72 h

4 d

0

0

1

0

0

0

0

0

Average*

0.0

1.67

0.0

0.0

3

 

 

 

 

1 h

0

2

0

0

24 h

0

2

0

0

48 h

0

1

0

0

72 h

4 d

0

0

0

0

0

0

0

0

Average*

0.0

1.0

0.0

0.0

4

 

 

 

 

1 h

0

2

0

0

24 h

0

1

0

0

48 h

0

1

0

0

72 h

4 d

0

0

1

1

0

0

0

0

Average*

0.0

1.0

0.0

0.0

5

 

 

 

 

1 h

1

2

0

0

24 h

0

1

0

0

48 h

0

1

0

0

72 h

4 d

0

0

1

0

0

0

0

0

Average*

0.0

1.0

0.0

0.0

6

 

 

 

 

1 h

0

2

0

0

24 h

0

2

0

0

48 h

0

0

0

0

72 h

4 d

0

0

0

0

0

0

0

0

Average*

0.0

0.67

0.0

0.0

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study assessing the skin irritation potential of glyceryl undecylenate was performed according to a protocol similar to OECD guideline 404 (Catroux, 1988). 0.5 mL of the test substance was applied for 4 hours to the shaved and abraded skin of 3 New Zealand White rabbits under occlusive conditions. The untreated skin site of the animals served as the control. The skin reactions (erythema and oedema) were scored 24 and 72 hours after patch removal. As no reading was performed 48 hours after patch removal, the mean scores were calculated by assuming the 48 hrs values were the same as those at 24 hours, making a worst-case assumption. For 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 in 1/3 animals and had cleared completely in 2/3. Slight edema 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. The irritation effects on abraded skin were slightly more severe than on intact skin, but all effects had cleared completely within 72 hours after patch removal. The individual mean erythema scores over the 24 and 72 hours reading time points (intact skin) were 0.67, 1.67 and 1.33, and the edema scores were 0, 0.67 and 0.67. The results obtained on abraded skin were not considered for hazard assessment. In conclusion, the test substance is considered to be non-irritating to the skin.

 

Eye irritation

An eye irritation study was performed with glyceryl undecylenate according to OECD guideline 405 (Redon, 1990). The undiluted test substance (0.1 mL) was instilled into one eye of 6 New Zealand White rabbits. The other eye remained untreated and served as the control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48 and 72 hours, and 4 and 7 days after test substance application. One hour after instillation of the test substance, 6/6 rabbits had obvious swelling (chemosis score 2) and 1/6 had some conjunctivae (score 1). At the 24-hour reading time point, some swelling (chemosis score 1) was observed in 2/6 animals, while 4/6 still showed obvious swelling (score 2). The chemosis gradually reduced in severity, persisting in 4/6 rabbits at the 48-hour reading time point, in 3/6 at the 72-hour reading time point, and in 1/6 until 4 days after instillation. No conjunctivae was observed in any animal from 24 hours after instillation. No irritating effects were seen on the iris and cornea in any animal at any reading time point, and no further local or systemic adverse effects were observed. The mean cornea, iris and chemosis scores over 24, 48, and 72 hours were 0 for all 6 animals, respectively. The mean score for conjunctivae over 24, 48, and 72 hours was 0.67, 1.67, 1.0, 1.0, 1.0 and 0.67 for the 6 animals.In conclusion, the test substance was not considered irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
The reliable study was selected.

Justification for selection of eye irritation endpoint:
The reliable study was selected.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.