Registration Dossier

Administrative data

Description of key information

In order to evaluate the skin as well as the eye irritating potential of the test substance two in vivo studies (OECD 404 and OECD 405) in rabbits were performed in 1985. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-07 to 1985-05-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The translation of the study report is available only. All scientific necessary information for evaluation is available. The study was performed according to OECD guideline 404.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
Executive summary:

In order to evaluate the irritant/corrosive potential of the test substance to the skin an in vivo test in rabbits was performed in 1985 which was in accordance to guideline OECD 404. 24 hours prior to treatment the animals back was shaved to receive a skin area of about 10 x10 square centimeters for treatment. Only animals with intact skin were chosen for the test. The 6 animals were each treated with 0.5 g test substance per animal on the right flank, whereas the left side serves as control. The treated area was covered by an occlusive bandage and fixed with a non-irritant tape for 4 hours. After these 4 hours, the bandage was removed and the skin washed with lukewarm water to remove remaining test substance. Mortality and clinical signs of toxicity were observed once daily. The skin was assessed for edema, eschar formation or erythema according to Draize, 60 minutes, 24, 48 and 72 hours after removing of bandage. No mortality occurred. No clinical signs of toxicity were observed. The overall mean scoring value is 0 for erythema and edema formation.

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Reason / purpose:
reference to other study
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-07 to 1985-05-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only the translation of the study report is available. All scientific necessary information for evaluation is available. The study was performed according to OECD guideline 405.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 (3 males + 3 females)
Details on study design:
In order to assess the eye irrtating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control. The treated eye remains unwashed.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours after treatment
Score:
1.78
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 -72 hours after treatment
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24- 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 14 days after treatment
Remarks on result:
other: In one animal a score of 2 was determined at day 14 after treatment. In one other animal the severity progessed up to score 4 at day 14 after treatment and it is not expected to be reversible within 21 days.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours after treatment
Score:
0.88
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 14 days after treatment in one animal the score was still 1; in one other animal the iris could not be assessed due to the cornea opacity.
Irritant / corrosive response data:
In order to assess the eye irritating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control. The treated eye remains unwashed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48, 72 and 96 hours after application of test item and additionally after 7 and 14 days due to some findings made. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:
No mortality or signs of systemic toxicity occurred.
Hyperemia of the conjunctiva was observed in all animals (score 1-2). In two of six animals this change was not reversible within the observation period of 14 days.
Chemosis of the conjunctiva (score1) was observed in all animals 24 hours after application. This effect was reversible within 72 hours.
Diffuse Corneal opacity areas (score 1, 2, 3) were observed in two of the six animals 48 hours after application and in all animals at 72 hours after application of the test substance. This observation was reversible in 4 animals by end of the 14-day observation period. The corneal opacity of the remaining two animals progressed up to complete opacity (score 4) in one case.
Hyperemia of the iris (score 1-2) was observed in 5 animals 48 hours after application and in all animals after 72 hours after application of the test substance. In one rabbit this observation was not reversible within the observation period and in a second rabbit the iris could not be evaluated due to the complete opacity of the cornea.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the test substance has to be classified Category 1 "causes serious eye damage", as the damage was not reversible within the observation period of 14 days and is not expected to be reversible within 21 days.
Executive summary:

In order to assess the eye irritating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of reach rabbit. The untreated eye serves as control. The treated eye remains unwashed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48, 72 and 96 hours after application of test item and additionally after 7 and 14 days due to some findings made. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia of the conjunctiva was observed in all animals (score 1-2). In two of six animals this change was not reversible within the observation period of 14 days.

- Chemosis of the conjunctiva (score1) was observed in all animals 24 hours after application. This effect was reversible within 72 hours.

- Diffuse Corneal opacity areas (score 1, 2, 3) were observed in two of the six animals 48 hours after application and in all animals at 72 hours after application of the test substance. This observation was reversible in 4 animals by end of the 14-day observation period. The corneal opacity of the remaining two animals progressed up to complete opacity (score 4) in one case.

- Hyperemia of the iris (score 1-2) was observed in 5 animals 48 hours after application and in all animals after 72 hours after application of the test substance. In one rabbit this observation was not reversible within the observation period and in a second rabbit the iris could not be evaluated due to the complete opacity of the cornea.

Based on the results of this study the test substance has to be classified Category 1 "causes serious eye damage", as the damage was not reversible within the observation period of 14 days and is not expected to be reversible within 21 days.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Reason / purpose:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A skin irritating study in 6 rabbits according to OECD 404 and an eye irritating study in 6 rabbits according to OECD 405 are available. Based on the results obtained from these studies the test substance is not skin irritating but it is corrosive to the eyes, as irreversible effects to the eyes were determined.


Justification for selection of skin irritation / corrosion endpoint:
The study was performed according to OECD guideline 404 and is sufficient for evaluating the endpoint.

Justification for selection of eye irritation endpoint:
The study was performed according to OECD guideline 405 and is sufficient for evaluating the endpoint.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Under the conditions of the OECD 404 test and the results obtained, it is concluded, that the test substance is not irritant to the skin. According to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, the test substance (Benzothiazol-2-ylthio)acetic acid has not to be classified for dermal irritancy.

Based on the results of the OECD 405 study the test substance causes serious damageto the eye, as irreversible effects on the eye were determined. According to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, the test substance (Benzothiazol-2-ylthio)acetic acid has to be classified Category 1, H318 "causes serious eye damage".