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Administrative data

Description of key information

Skin irritation/corrosion: not irritating (EU Method B.4, GLP)

Eye irritation/corrosion: not irritating (EU Method B.5; GLP)

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:
2002-04-10 to 2002-04-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
purity and stability of test item not given; 60 minute observation was missing; information on strain was missing
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2001-08-22
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, cool and dark room
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen, Germany
- Weight at administration day: 2650 to 3135 g
- Housing: housed individually in zinc wire cages (surface: 2450 cm², height: 42 cm) without bedding material
- Diet (ad libitum): Raiffeisen Ringfutter Kaninchen, Trockenfutter 52/P Raiffeisen, Kraftfutter Kehl
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 -23°C
- Relative humidity: 30 -70 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test material moistened with the vehicle
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk was shaved (area: 3 x 5 cm²) and the test material was applied. The test area was covered with a patch (area: 6 cm) that was fixed with occlusive dressing. The dressing was fixed with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was washed with 0.9 % NaCl solution
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS :
Days 1, 2, 3, 4, 5, and 7

SCORING SYSTEM: according to the Draize scale

EXAMINATIONS:
Mortality, clinical signs, behaviour, body weight, and skin reactions
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was observed throughout the study.
Other effects:
- no mortality was observed.
- no clinical signs were observed during the observation period.
- behaviour was calm and alert. It did not differ from rabbits, which were not involved in the study.
- rabbits gained body weight throughout the observation period, except for one male rabbits which lost weight on observation day 1. Afterwards, the male rabbit also gained throught the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
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:
2002-04-10 to 2002-04-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
purity and stability of test item not given; strain not stated
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2001-08-22
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, cool and dark room
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen, Germany
- Weight at administration day: 2960 to 3076 g
- Housing: housed individually in zinc wire cages (surface: 2450 cm², height: 42 cm) without bedding material
- Diet (ad libitum): Raiffeisen Ringfutter Kaninchen, Trockenfutter 52/P Raiffeisen, Kraftfutter Kehl
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23°C
- Relative humidity: 30 -70 %
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item was applied into the conjunctival sac of the right eye. The left eye was left untreated ansd served as control.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1 hour and Days 1, 2, 3, 4 , 5, and 7 after administration
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was washed with 0.9 % NaCl solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to the Draize scale

EXAMINATIONS:
Mortality, clinical signs, behaviour, body weight, and eye reactions
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No conjunctival redness or chemosis were observed in any of the three rabbits. In addition, no effects on the cornea or iris were observed.
Other effects:
- no mortality was observed.
- behaviour was calm and alert. It did not differ from rabbits, which were not involved in the study.
- rabbits gained body weight throughout the study period.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The substance was not observed to be irritating to the skin in a reliable in vivo skin irritation study according to EU Method B.4.

Eye irritation

The substance was not observed to be irritating to the eyes in a reliable in vivo eye irritation study according to EU Method B.5.

Justification for classification or non-classification

Skin irritation

The substance does not possess a skin irritating potential based on an in vivo skin irritation study according to EU Method B.4 (1992). The substance does not require classification as skin irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.

Eye irritation

The substance does not possess an eye irritating potential based on an in vivo eye irritation study according to EU Method B.5 (1992). The substance does not require classification as eye irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.