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Diss Factsheets

Administrative data

Description of key information

According to an OECD TG 404 compliant study in the rabbit, the test item was found to be not irritating to the skin (reference 7.3.1 -1).

According to an OECD TG 405 compliant study in the rabbit, the test item was found to be not irritating to the eye (reference 7.3.2 -1).

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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL BR
Type of coverage:
semiocclusive
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
none
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not considered a skin irritant.
Executive summary:

An in vivo skin irritation test according to OECD 404 was performed to to evaluate the irritating potential of the test item to the skin.

No mortality and signs of systemic toxicity were observed. No signs of irritation to the rabbit skin were observed. The mean scores for the readings at 24 - 72 hours were 0.

The test item did not show any skin irritating potential.

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:
26 September 1996 - 14 October 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl: KBL (NZW) BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg
- Age at study initiation: approx. 25 weeks
- Weight at study initiation: 3.81 - 3.99 kg
- Housing: not specified
- Diet: Altromin Standard Diet TPF ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20°C
- Humidity (%): 40 - 66%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount appied: 100 mg
Duration of treatment / exposure:
single application, rinsing of eyes of not performed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: not specified
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
After installation conjunctival redness (score 1, all animals) and chemosis (score 2, 2/3 animals) was observed, being fully reversible within 24 hours.
Other effects:
2 animals showed outflow. This effect disappeared within 24 h reversibly.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test item was not considered to be an eye irritant.
Executive summary:

An in vivo eye irritation test according to OECD 405 was performed to to evaluate the eye hazard potential of the test item.

No mortality and signs of systemic toxicity were observed. The body weight development was found to be in the normal range of this rabbit strain.

After single installation of 0.1 g test item into the conjunctival sac of the left eye, no signs of irritation to the cornea and iris were observed. The conjunctivae showed redness (score 1) in all rabbits at the first reading. Chemosis (score 2) was seen in two animals at the first reading. All findings were found to be fully reversible within 24 hours after test item installation. The untreated eyes were normal.

The cumulative mean scores per animal for cornea, iris and conjunctivae were 0 for the readings at 24 - 72 hours.

The test item did not show any eye irritating potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

An in vivo skin irritation test according to OECD 404 was performed to to evaluate the irritating potential of the test item to the skin.

No mortality and signs of systemic toxicity were observed. No signs of irritation to the rabbit skin were observed. The mean scores for the readings at 24 - 72 hours were 0.

The test item did not show any skin irritating potential (reference 7.3.1 -1).

Eye irritation

An in vivo eye irritation test according to OECD 405 was performed to to evaluate the eye hazard potential of the test item.

No mortality and signs of systemic toxicity were observed. The body weight development was found to be in the normal range of this rabbit strain.

After single installation of 0.1 g test item into the conjunctival sac of the left eye, no signs of irritation to the cornea and iris were observed. The conjunctivae showed redness (score 1) in all rabbits at the first reading. Chemosis (score 2) was seen in two animals at the first reading. All findings were found to be fully reversible within 24 hours after test item installation. The untreated eyes were normal.

The cumulative mean scores per animal for cornea, iris and conjunctivae were 0 for the readings at 24 - 72 hours.

The test item did not show any eye irritating potential (reference 7.3.2 -1).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on local irritation properties, the test item does not require classification as skin or eye irritant according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.