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Diss Factsheets

Administrative data

Description of key information

Skin irritation: Not irritant

Eye irritation: Irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 08, 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test comparable to guideline study with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetica" (1959) of the US Association of Food and Drug Officials'(AFDO)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.8 to 2.3 kg
- Housing: housed singly in metal cages (overall dimensions 47x32x34 cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
6 rabbits were shaved one day before treatment with an electric clipper-on the flanks .
The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied imdiately to the prepared skin. The patch was covered wíth an-impermeable foil of 5x5 cm, which was fixed to the body of the animal with adhesive tape.
The test substance was applied to each side in quantities of 0.5 g . Before application the test materiel was wetted with tap water.
The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 7 days.
Irritation parameter:
erythema score
Basis:
animal: 426, 428, 430, 439, 441, 443
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 426, 428, 430, 439, 441, 443
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Interpretation of results:
other: Not classified
Remarks:
According to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Non irritant
Executive summary:

Method

The skin irritation was determined in an irritation test on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO)", similar to OECD guideline 404.

6 rabbits were shaved one day before treatment with an electric clipper-on the flanks . The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied imdiately to the prepared skin. The patch was covered wíth an-impermeable foil of 5x5 cm, which was fixed to the body of the animal with adhesive tape. The test substance was applied to each side in quantities of 0.5 g . Before application the test materiel was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 7 days.

Conclusion

Not 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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 08, 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test comparable to guideline study with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2.3 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 minute
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 male and 3 female)
Details on study design:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with
physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days.
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 490, 497
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 490, 497
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 490
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 497
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 488, 497
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 490
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Interpretation of results:
other: Irritating
Remarks:
According to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Irritant
Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 405.

0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with

physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days.

 

Result:

Irritant

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.

 

A substance has to be classified as Category 2 (Irritant) if shows:

(1) Mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

Under the test condition no signs of irritation were observed therefore the test substance has not need to be classified.

 

Eye Irritation

According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

 

A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

— at least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 3 and/or

— iritis > 1.5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

 

A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:

at least in 2 of 3 tested animals, a positive response of:

-          corneal opacity ≥ 1 and/or

-          iritis ≥ 1, and/or

-          conjunctival redness ≥ 2 and/or

-          conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

 

Under the test condition the tested substance is classified as Eye Irr. 2 (H319), according to the CLP Regulation.