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Diss Factsheets

Administrative data

Description of key information

Eye irritation - In vitro eye irritation (isolated chicken eyes test): Not classified as a severe irritant and not classified as non-irritant. In vivo study required for classification.

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:
15-18 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: S&K LAP Kft, Hungary- Age at study initiation: 14 weeks old- Weight at study initiation: 3256-3521g- Housing: Individual- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 25 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18.4-22.1- Humidity (%): 32-70- Air changes (per hr): 15-20- Photoperiod (hrs dark / hrs light): 12 hours
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes and 24, 48 and 72 hours after patch removal
Number of animals:
3 males
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The substance was observed to not be dermally irritant following exposure to rabbit skin
Executive summary:

The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.

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:
30 September to 10 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with OECD test guidelines in compliance with GLP and reported with a valid certificate
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: S&K LAP Kft, Hungary- Age at study initiation: 14 weeks old- Weight at study initiation: 3598-3864g- Housing: Individual- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 31 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17.5-20.8- Humidity (%): 29-78- Air changes (per hr): 15-20- Photoperiod (hrs dark / hrs light): 12 hours
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g of test substance.
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48 and 72 hoursnd 1 week after application
Number of animals or in vitro replicates:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
redness
Basis:
mean
Time point:
other: 24 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
< 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
redness
Basis:
mean
Time point:
other: 48 hours
Score:
1.67
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
redness
Basis:
mean
Time point:
other: 72 hours
Score:
1.33
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Due to staining, clear scoring was not possible so estimated scores were estimated scores are listed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
< 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Scoring was not posisble in all animals after 24 hours due to staning of the eyes ad fur around the eyes.

The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, it was not possible to score redness, opacity or iris effects at the early time points in some animals. However, since the colour cleared sufficiently to make a score at 48 and 72 hours and there were no observed effects of opacity or iris effects there was assumed to have been no iris effects and no effects exceeding an opacity of 2 at any time. Where redness scording was not posisble, it was estimated that the score was a maximum of 3 at 24 hours after exposure based on scientific opinion and experience of the laboratory staff.

Interpretation of results:
moderately irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The substance caused significant staining, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.
Executive summary:

The primary eye irritation has been assessed by instalation of 0.1g of test substance. to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP.

The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

IN VITRO SKIN IRRITATION STUDY

The dermal irritation of the substance has been assessed in vitro using the Episkin test according to the OECD 439 guideline in compliance with GLP. Under the conditions of the test the substance is shown to be non irritant.

IN VIVO SKIN IRRITATION STUDY

The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.

IN VITRO EYE IRRITATION STUDY

An in vitro eye irritation study of the test item BK-659 was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (26thJuly 2013).

After the zero reference measurements, the eye was held in horizontal position and 30 mg of BK-659 was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 mg Imidazole. The negative control eye was treated with 30 μL of Saline (Salsol solution, NaCl 0.9% w/v).

Based on this in vitro eye irritation in the isolated chicken eyes test with BK-659, the test item is not classified as a severe irritant and not classified as non-irritant. It is concluded that an in vivo study is required for classification.

IN VIVO EYE IRRITATION STUDY

The primary eye irritation has been assessed by instalation of 0.1g of test substance. to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP.

The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.


Justification for selection of skin irritation / corrosion endpoint:
The study is classed as K1 quality

Justification for selection of eye irritation endpoint:
The study is classed as K1 quality

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

IN VIVO EYE IRRITATION STUDY

The primary eye irritation has been assessed by instalation of 0.1g of test substance. to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP.

The test item is a dye-like substance. There was no permanent staining, but due to the intene colour, without washing, affecting scoring at some of the early time points, but significant or persistent conjunctival or corneal irritant effects. All effects were fully reversible within 1 week. The effects of the substance are considered to classify the substance as a Cat 2 irritant.