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Diss Factsheets

Administrative data

Description of key information

Skin Irritation: Non irritant

Eye Irritation: Non irritant

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
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)
Principles of method if other than guideline:
patch test
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.4-1.7 kg
- Housing: singly in metal cages (overall dimensions 47x32x34 cm)
- Diet: Standard diet of Nafag ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 14 hours light
Type of coverage:
occlusive
Preparation of test site:
other: right shaved; left shaved and scarified
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): wetted with tap water
Duration of treatment / exposure:
24 h
Observation period:
8 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: 2 sites of 2.5 x 2.5 cm
- Type of wrap if used: impermeable foil of 5 x 5 cm, which was fixed to the body of the animals with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: 188, 189, 190, 191, 192
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 187
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 1.66
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 188, 189, 190, 191, 192
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 187
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Interpretation of results:
other: CLP criteria not met
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) of the US Association of Food and Drug Officials (AFDO)", similar to the OECD Guideline 404.

 

Result

Non 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:
June 1 to 4, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintier farm Madoerin AG EH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.8 kg
- Housing: Indlvidually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: PeIIeted standand KIiba 34L, Batch 25/87 and 26/87 rabbit maintenance diet ("KIiba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: Five days under laboratory conditions aften veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark.

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 457
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 458
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: not washed eye
Irritation parameter:
iris score
Basis:
animal: 457, 458, 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 457, 458, 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 457
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 458
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not washed eye
Irritation parameter:
chemosis score
Basis:
animal: 459
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: not washed eye
Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritating
Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to OECD Guideline 405 and EU Method B.5.

 

Observation:

The mortality was evaluated daily while the body weights was assessed at day 1 and at termination of the test on a Mettler PK 16 balance. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The corrosive properties of the test article and the colour of the treated eye were described and recorded. 

Result:

Corrosive

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The test substance was evaluated for its skin irritation potential according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)", similar to the OECD Guideline 404. The composition in unknown.

0.5 g of the test substance was applied on the skin of six rabbits using gauze patches, then covered by impermeable material. After 24 hours the gauzes were removed and the skin observed for 8 days.

The mean score of observed values of irritation/corrosion , calculated for each rabbit, after 24, 48, 72 hours, were always under the limit for irritation potential set out in the OECD guideline, therefore the substance is considered as not irritant.

To support this result a second study conducted on the Similar Substance 02 was taken in account. More datails about Similar Substance 02 are reported in the Read Across Hypothesis and Justification attached in section 13.

The skin irritation was determined in an irritation test on rabbits according to 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. The test substance resulted to be not irritant.

Eye Irritation

The test substance was evaluated for its eye irritation potential according to the OECD Guideline 405 and EU Method B.5.

The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. The eyes of the animals were observed for 72 hours.

The mean score of observed values of irritation/corrosion , calculated for each rabbit, after 24, 48, 72 hours, were always under the limit for irritation potential set out in the OECD guideline, therefore the test item does not show any eye irritation potential.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.

Three subcategories are provided within the Corrosive category 1:

Subcategory 1A where responses are noted following up to 3 minutes exposure and up to 1 hour observation;

Subcategory 1B where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days;

Subcategory 1C where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days

To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- 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

- 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

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

The substance is not classified as skin irritant because in the performed test it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.

 

EYE IRRITATION

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.

Irreversible effects on the eye (Category 1):

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.

These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Substances are also classified in Category 1 if they fulfil the criteria of corneal opacity ≥ 3 or iritis > 1,5 detected in a Draize eye test with rabbits, recognising that such severe lesions usually do not reverse within a 21-day observation period.

The substance does not meet the requirements to be classified in Category 1.

Irritating to eyes (Category 2)

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.

The test substance does not meet the requirements to be classified.