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Administrative data

Description of key information

Skin irritation: not irritating (OECD 404 (1981); GLP compliant)

Eye irritation: not irritating (OECD 405 (1987); GLP compliant)

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)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
fur clipped at least 15 h before test begin; examination for erythema & oedema at 30 - 60 min. after test patch removal & 24 h, 48 h, 72 h after the beginning of application; modified Draize scoring system; reading skin reaction at 30 - 60 min. missing.
GLP compliance:
yes
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.62 - 2.87 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm; no bedding in the cages; sawdust in the waste trays; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: at least 15 hours before the beginning of the study the upper third of the back or flanks were clipped. The application area was 2.5 cm x 2.5 cm. The test patch (2.5 cm x 2.5 cm) was covered with a dose of the unchanged test substance and has been moistened with aqua bidest.. Because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: at the end of the exposure period
- Washing: with lutrol and lutrol/water (1:1)

SCORING SYSTEM: according to a modified Draize scale.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe

OBSERVATIONS:
Shortly before application of the test substance the weight of the rabbits was determined. Symptoms were recorded.
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:
anmimal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in all animals at a 4 hour observation.
Very slight erythema was observed in one animal at the 24 hour observation.
No erythema or oedema was observed in two animals at the 24, 48 and 72 hour observations.
Interpretation of results:
GHS criteria not met
Conclusions:
Sicocer F Eisenrosa 2320 is not irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
: scoring according to modified Draize system (different wording); it was not stated, if the eyes were examined within 24 hours before testing starts; it was not stated, if the eyelids were held together after application of the test substance.
GLP compliance:
yes
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 2.60 kg and 3.07 kg; females: 2.78 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm; no bedding in the cages; sawdust in the waste trays; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- Temperature: 20 - 24 °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): A single application of 0.1 mL bulk volume (about 118 mg of the comminuted test substance) was applied to the conjunctival sac of the right eyelid. The untreated eye served as control.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
2 males / 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the substance was not washed out.

SCORING SYSTEM: according to a modified Draize system

Chemosis and cornea (opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe

Conjunctivae redness:
0 = normal
1 = slight
2 = well-defined
3 = severe

Iris:
0 = normal
1 = circum-corneal injection
2 = iritis

Area of cornea involved:
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4

Discharge:
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased

OBSERVATIONS:
Weight determination: shortly before application of the test substance.
Symptoms were observed.
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:
Slight conjunctivae redness and slightly increased discharge were observed in all animals at the 1 hour observation.
Slight conjunctivae chemosis was observed in one animal at the 1 hour observation.
No ocular effects were observed during the 24, 48 and 72 hour observations.
Interpretation of results:
GHS criteria not met
Conclusions:
Sicocer F Eisenrosa 2320 is not irritating to the eye.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

One reliable in vivo study described by Rossbacher (1992)(OECD 404 (1981); GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the skin.

Eye irritation

One reliable in vivo study described by Rossbacher (1992) (OECD 405 (1987); GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eyes.

Justification for classification or non-classification

Skin irritation

Reference Rossbacher (1992) is considered as the key study for in vivo skin irritation and will be used for classification. The skin irritation was scored according to a modified Draize scale. The mean score (24, 48, 72h after beginning of application) for oedema was 0 for all animals. The mean score for erythema was as follows for the three animals: 0, 0, and 0.33, respectively. The ocular effects were fully reversible within 48 hours and the study was terminated after the 72 hour observation. According to regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as skin irritant.

Eye irritation

Reference Rossbacher (1992) is considered as the key study for in vivo eye irritation and will be used for classification. During the study the test item was applied to one eye of three animals each and the eye irritation was scored according to a modified Draize scale.The corneae, irises and conjunctivae were not affected by instillation of the test item. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes.

Respiratory irritation

The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.