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Description of key information

Based on an in vivo skin irritation test, conducted according to OECD 404 test guideline and GLP principles, it was concluded that the substance is not irritating to the skin. Based on an in vivo eye irritation study, conducted in accordance with OECD 405 test guideline and according to GLP principles, it was concluded that the substance is not irritating to the eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 April, 1995 - 07 April, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 1349 - 1757 g
- Housing: Animals were housed individually in labelled cages with perforated floors.
- Diet: Free access to standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands).
- Water: Free access to tap water diluted with decalcified water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test substance was moistened with distilled water.
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 grams

Duration of treatment / exposure:
Single application.
Observation period:
14 days.
Number of animals:
3 males.
Details on study design:
TEST SUBSTANCE PREPARATION
The powdery test substance was moistened with distilled water, immediately before application.

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). Whenever considered necessary the skin areas concerned were re-clipped at least 3 hours before the observations, to facilitate scoring

The test substance was applied to the skin of one flank, using a patch of 2x3 cm. A similar patch (but without test substance and water) was applied to the contralateral flank, to act as a procedural control. Both patches were mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.

OBSERVATIONS (kort allemaal!)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application)
- Necropsy: Not performed.
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was observed and there was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
other: Not irritating
Remarks:
according to Regulation (EC) No 1272/2008 and its amendments.
Conclusions:
In an skin irritation study with male rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.

Executive summary:

Alcamizer 5 was tested in a skin irritation/corrosion study with male rabbits, performed according to OECD 404 test guideline and GLP principles.

No skin irritation was observed and there was no evidence of a corrosive effect on the skin. No staining of the treated skin was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Alcamizer 5 does not have to be classified and has no obligatory labelling requirement for skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).

Endpoint:
skin irritation: 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
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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 April, 1995 - 13 April, 1995
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
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Animals used withihn the study were approx. 8-10 weeks old
- Weight at study initiation: Body weights were 1585 - 1990 g
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands). In addition, hay was provided once a week.
- Water: Free access to tap water diluted with decalcified water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL- Amount applied: 46 ± 1 mg (volume of 0.1 mL)
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
3 males
Details on study design:
TREATMENT
On test day 1, the test substance was instilled in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS (beschrijf beperkt)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation).
- Necropsy: Not performed.
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Instillation of the test substance into one eye of each animal resulted in effects on the iris and the conjunctivae.
The irritation of the iris had resolved within 24 hours in all animals. The irritation of the conjuctivae consisted of redness, chemosis and discharge, which had resolved within 72 hours after instillation in all animals. There was no evidence of ocular corrosion.
Other effects:
No staining of peri-ocular tissues by the the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
other: Not classified
Remarks:
according to Regulation (EC) No 1272/2008 and its amendments.
Conclusions:
In an eye irritation study with male rabbits, performed according to OECD 405 test guideline and GLP principles, limited irritation was observed.
Executive summary:

Alcamizer 5 was tested in an eye irritation/corrosion study with male rabbits, performed according to OECD 405 test guideline and GLP principles.

Instillation of the test substance into one eye of each animal resulted in effects on the iris and the conjunctivae.

The irritation of the iris had resolved within 24 hours in all animals. The irritation of the conjuctivae consisted of redness, chemosis and discharge, which had resolved within 72 hours after instillation in all animals. There was no evidence of ocular corrosion.

No staining of peri-ocular tissues by the the test substance was observed.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Alcamizer 5 does not have to be classified and has no obligatory labelling requirement for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).

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

Respiratory irritation

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

Additional information

Skin irritation:

Alcamizer 5 was tested in a skin irritation/corrosion study with male rabbits, performed according to OECD 404 test guideline and GLP principles.

No skin irritation was observed and there was no evidence of a corrosive effect on the skin. No staining of the treated skin was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Eye irritation:

Alcamizer 5 was tested in an eye irritation/corrosion study with male rabbits, performed according to OECD 405 test guideline and GLP principles.

Instillation of the test substance into one eye of each animal resulted in effects on the iris and the conjunctivae.

The irritation of the iris had resolved within 24 hours in all animals. The irritation of the conjuctivae consisted of redness, chemosis and discharge, which had resolved within 72 hours after instillation in all animals. There was no evidence of ocular corrosion.

No staining of peri-ocular tissues by the the test substance was observed.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Justification for classification or non-classification

Based on the study results, Alcamizer 5 does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).