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Administrative data

Description of key information

Skin irritation: not classified (OECD 404, GLP, K, rel.2)

Eye irritation: Cat. 2B (OECD 405, GLP, K, rel.2)

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:
December 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 404 is followed and study is performed according to GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2. If substance identity and composition was reported in study report then reliability would turn into 1.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
- Age of animals is not mentioned.
GLP compliance:
yes
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, France
- Age at study initiation: no info
- Weight at study initiation: on the day of treatment 2.5 ± 0.3 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: December 12, 1995 To: December 17, 1995
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per animal
- Concentration (if solution): test material was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
- Initial test in 1 animal: one flank 3 minutes; other flank 4 hours
- Confirmatory test in 2 animals: 4 hours
Observation period:
- 3 days (approximately 1, 24, 48 and 72 hours after patch removal)
- when there is persistent cutaneous irritation after 72 hours the observation period is extended to a maximum of 14 days (until day 15)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: A single dose of 0.5 ml of the test material was applied to a 6 cm2 gauze pad, which was then applied to the right flank (4 hours in all animals) or the left flank (3 minutes in 1 animal) of the animals. The untreated skin served as control.
- % coverage: no info
- Type of wrap if used: The test material and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was noted at removal of the dressing.
- Time after start of exposure: not applicable


SCORING SYSTEM: see below
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation or corrosion mentioned.
Other effects:
No.

Summary of dermal lesions on clipped and intact skin (following 4-h application).

Remark: No cutaneous reactions were observed after an application of three minutes during the initial test in one animal.

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

1

1

2

3

7

14

 

 

 

01

Erythema/ eschar

Oedema

0

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

 

 

0

02

Erythema/ eschar

Oedema

0

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

03

Erythema/ eschar

Oedema

1

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

Mean Group

 

 

 

 

 

 

 

 

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

 In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of Aqualenc F was applied on the clipped skin of 3 males New Zealand White rabbits.

An initial test was performed in one animal with exposure periods of 3 minutes and 4 hours. No cutaneous reactions were observed after an application of 3 minutes. A confirmatory is performed in two other animals.

The single 4-hour, semi-occluded application of the test material to the intact skin of all three animals produced immediately after patch removal very slight erythema at the test site of one animal. This effect was gone at 24 hours after patch removal. Necrosis and ulceration were not reported.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

Under the test conditions, test substance is not classified according to the Annex VI of Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

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:
April 1996 - May 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 405 is followed and study is performed according to GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2. If substance identity and composition was reported in study report then reliability would turn into 1.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
- age of animals is not mentioned
- no initial and confirmatory test (however, no severe effects were anticipated)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no info
- Weight at study initiation: on the day of treatment 2.3 ± 0.1 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: April 25, 1996 To: May 16, 1996
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the left eye
- Concentration (if solution): test article was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single application into the left eye: the lower and upper eyelids were held together for about one second to avoid any loss of test substance.
Observation period (in vivo):
- approximately 1 hour and 24, 48 and 72 hours after administration
- when there is persistent ocular irritation after 72 hours the observation period is extended to a maximum of 21 days (until day 22)
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed
- Time after start of exposure: not applicable


SCORING SYSTEM: see below


TOOL USED TO ASSESS SCORE:
- Cornea: 2 drops of 0.5% sodium fluorescein solution; direct examination or, if necessary, with an Ultra-Violet lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 5 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
No ocular corrosion mentioned.
Other effects:
Conjunctival reactions in all animals form day 1 up to days 4,5 and 6. Accompanied by clear or purulent ocular discharge for 24 to 78 hours. No other ocular reactions.

Summary of ocular lesions

Animal No. Effect Hours Days after application Mean score Chemosis Days 1/2/3 Mean score Redness Days 1/2/3 Mean score Iris Days 1/2/3 Mean score Cornea Days 1/2/3
1 1 2 3 4 5 6
1 Chemosis 2 1 1 0 0 - - 0.7
Redness 0 1 1 1 0 - - 1
Iris 0 0 0 0 0 - - 0
Cornea 0 0 0 0 0 - - 0
2 Chemosis 1 1 1 0 0 0 0 0.7
Redness 0 2 2 2 2 1 0 2
Iris 0 0 0 0 0 0 0 0
Cornea 0 0 0 0 0 0 0 0
3 Chemosis 2 1 1 1 0 0 - 1
Redness 0 2 2 2 1 0 - 2
Iris 0 0 0 0 0 0 - 0
Cornea 0 0 0 0 0 0 - 0
Mean all animals 0.8 1.7 0 0

- Ocular examination not performed

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions, the test material is classified as H319 "Irritating to eyes" Category 2 according to the Annex VI of the Regulation (C) No. 1272/2008 (CLP) and as mild-irritant to the eyes (Cat. 2B) according to the GHS.
Executive summary:

In an eye irritation study performed according to the OECD Guideline No. 405 and in compliance with GLP, 0.1 mL of undiluted test material (Aqualenc F) was instilled into the left conjunctival sac of 3 male New Zealand White rabbits while the right eye served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 1, 24, 48 and 72 after instillation and then daily for 3 days. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.

The calculated mean score for each individual lesion for all the animals within 3 scoring times (24, 48 and 72 h) were: 1.7 for redness, 0.8 for chemosis, 0.0 for iris lesions and corneal opacity.

The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7 / 0.7 / 1.00 for chemosis, 1.00 / 2.00 / 2.00 for redness, and 0.0 / 0.0 / 0.0 for iris lesions and for corneal opacity.

Very slight to slight conjunctival reactions were observed in all animals from day 1 up to days 4, 5 or 6. They were accompanied by a clear or purulent ocular discharge for 24 to 48 hours. No other ocular reactions were recorded.

Under the test conditions, the test material is classified as H319 "irritating to the eyes" Category 2 according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and as mild-irritant to the eyes (Cat. 2B) according to the GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A key study was identified (Jouffrey, 1996). In this dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of Aqualenc F was applied on the clipped skin of 3 males New Zealand White rabbits.

An initial test was performed in one animal with exposure periods of 3 minutes and 4 hours. No cutaneous reactions were observed after an application of 3 minutes. A confirmatory is performed in two other animals.

The single 4 -hour, semi-occluded application of the test material to the intact skin of all three animals produced immediately after patch removal very slight erythema at the test site of one animal. This effect was gone at 24 hours after patch removal. Necrosis and ulceration were not reported.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

 

Eye irritation:

A key study was identified (Jouffrey, 1996). In this eye irritation study performed according to the OECD Guideline No. 405 and in compliance with GLP, 0.1 mL of undiluted test material (Aqualenc F) was instilled into the left conjunctival sac of 3 male New Zealand White rabbits while the right eye served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 1, 24, 48 and 72 after instillation and then daily for 3 days. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.

The calculated mean score for each individual lesion for all the animals within 3 scoring times (24, 48 and 72 h) were: 1.7 for redness, 0.8 for chemosis, 0.0 for iris lesions and corneal opacity.

The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7 / 0.7 / 1.00 for chemosis, 1.00 / 2.00 / 2.00 for redness, and 0.0 / 0.0 / 0.0 for iris lesions and for corneal opacity.

Very slight to slight conjunctival reactions were observed in all animals from day 1 up to days 4, 5 or 6. They were accompanied by a clear or purulent ocular discharge for 24 to 48 hours. No other ocular reactions were recorded.

Justification for classification or non-classification

Harmonised classification

The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008.

Self-classification

Based on the available data:

- no additional self-classification is proposed for the registered substance regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS

- the registered substance is classified as Category 2 (H319 "irritating to the eyes") according to the annex I of the Regulation EC No. 1272/2008 (CLP) and as mildly irritanting to the eyes (Cat. 2B) according to the GHS.

No data was available regarding respiratory irritation.

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