GASIR1

Endpoint summary

Description of key information

In an in vivo skin irritation assay conducted in accordance with OECD Test Guideline 404 and to GLP, Gasir 1 was considered to be non-irritating to skin.

 

Based on an in vivo eye irritation study, conducted in accordance with OECD Test Guideline 405 and to GLP, Gasir 1 is considered to be non-irritant to eye according to CLP.

 

No relevant respiratory tract irritation data were identified.

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

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Méthode B4 de la Directive de la Commission 2004/73/CE.

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Perceval Ltd, Moston; Sandbach, Cheshire, UK
- Age at study initiation:12-20 weeks
- Weight at study initiation:2-3.5kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: 0,5 ml distilled water

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage:no data
- Type of wrap if used: an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done):gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4h

SCORING SYSTEM:Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Max. score:

0

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: (related to all animals)

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Max. score:

0

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: (related to all animals)

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study

Other effects:

Red/brown coloured staining was noted at all treated skin sites througout the study. The staining did not affect evaluation of skin responses.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
• Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three

rabbits produced no evidence of skin irritation.

Conclusion. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

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

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: Méthode B5 de la Directive de la Commission 2004/73/CE.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Perceval Ltd, Moston; Sandbach, Cheshire, UK
- Age at study initiation:12-20 weeks
- Weight at study initiation:2-3.5kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Vehicle:

unchanged (no vehicle)

Controls:

other: In one animal, one eye was treated, the other was the control

Amount / concentration applied:

100mg

Duration of treatment / exposure:

72h

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 1 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 1 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 1 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48h, 72h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1 h

Score:

1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Other effects:

Dark red-coloured residual test material was noted in all treated eyes at the 1-hour observation and in one treated eye at the 24-hour observation.
Dark red-coloured staining of the fur was noted around all treated eyes during the study.

Interpretation of results:

GHS criteria not met

Remarks:

According to the CLP regulation the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met

Conclusions:

The test material produced a maximum group mean score of 6.0 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

According to the CLP regulation, the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met

 
  

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
• Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Conclusion.

The test material produced a maximum group mean score of 6.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified

Kay and Calandra classification system.

According to the CLP regulation, the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met

 

Table 3.3 2Eye irritation
Category	Criteria
Category 2	Substances that produce in at least in 2 of 3 tested animals, a positive response of: (a) corneal opacity≥1 and/or (b) iritis ≥ 1, and/or (c) conjunctival redness ≥ 2 and/or (d) conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

 

  

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No respiratory tract irritation data were identified. A study was not conducted as it is not a REACH Standard Information Requirement.

Justification for classification or non-classification

Based on the results of the available and reliable in vivo skin irritation study, there is no requirement to classify Gasir 1 for skin irritation under EU CLP. 

Based on the results of the available and reliable in vivo eye irritation study, there is no requirement to classify Gasir 1 for eye irritation according to EU CLP criteria (EC 1272/2008).