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Administrative data

Description of key information

Skin: The test item is regarded as corrosive to the skin (reference 7.3.1 -1).

Eyes: The substance caused severe damage to the eyes (reference 7.3.2 -1).

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:
June 19, 2000 - August 16, 2000
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:
July 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, KiBlegg
- Age at study initiation: about 18 weeks
- Weight at study initiation: 3.39 kg
- Housing: special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm;) with plastic grids placed on mobile racks
- Diet: ad libitum, diet for rabbits No. 814 and No. 5697, Eberle Nafag
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 62 to 73
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Aqua pro injectione
Controls:
no
Amount / concentration applied:
TEST MATERIAL
0.5 g of the test material was mixed with some drops of Aqua pro injectione and spread onto a patch of about 6 cm2. The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: animal's back and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing: not specified

SCORING SYSTEM:
- Method of calculation: according to DRAIZE
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
After a single application to the intact dorsal skin of a rabbit, for a 4 hours period of exposure under semiocclusive conditions, necrosis (Erythema and eschar formation: score 4) of the skin was observed in the treated area. Therefore the study was finished. No signs of pain or itching were detected.
Other effects:
-Results of Pre-test:
The test material was screened for its irritating potential with the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The egg shell was entered above the air cell by a dentist's rotary and then pared off. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized egg, which lies immediately below. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is, thus, regarded as being insensitive to pain.In this model the cumulative irritation score was 8.84. This revealed a moderate irritating potential and the animal study was started with one rabbit.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The test item is regarded as corrosive to the skin.
Executive summary:

A study according to OECD TG 404 was performed to determine irritative/corrosive properties of the test item to the skin. The study was started with one rabbit. For the primary skin irritation, the test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of one previously shaven rabbit for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed after removal of the patches.

Strong local changes were seen, the study was finished and the rabbit was sacrificed. Necrosis was seen at the application site directly after removal of the patches. No signs of pain or itching could be observed.

Therefore, the test item is regarded as corrosive to the skin.

Endpoint:
skin corrosion: 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:
adverse effect observed (corrosive)

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:
August 16, 2000
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:
February 24, 1987
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, KiBlegg
- Age at study initiation: about 18 weeks
- Weight at study initiation: 3.37 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm;) with plastic grids placed on mobile racks
- Diet: ad libitum, diet for rabbits No. 814 and No. 5697, Eberle Nafag
- Water: ad libitum), tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 62 to 73
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g


Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Strong local irritations were seen, the study was finished, and the rabbit was humanely sacrificed. Immediately after instillation opacity (score 4) of the cornea was observed. The iris was not visible. The conjunctivae showed redness (score 3), chemosis (score 4) and discharge (score 3). The untreated eye was unchanged.
Other effects:
Results of Pretest:
The test material was screened for its irritating potential with the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The egg shell was entered above the air cell by a dentist's rotary and then pared off. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized egg, which lies immediately below. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is, thus, regarded as being insensitive to pain. The cumulative irritation score was 8.84. This revealed a moderate irritating potential and the animal study was started with one rabbit.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance was regarded as corrosive to the eyes.
Executive summary:

A study according OECD TG 405 was conducted. According to the guideline the exposure of one animal is recommended if it is suspected that the test material might produce severe irritation. Therefore the study was started with one rabbit. For the primary eye irritation test, 0.1 g test material was applied into the conjunctival sac of the rabbit.

The first examination of the eyes followed immediately after instillation. No signs of pain were observed. Strong local irritations were seen, the study was finished, and the rabbit was sacrificed.

Immediately after instillation opacity (score 4) of the cornea was observed. The iris was not visible. The conjunctivae showed redness (score 3), chemosis (score 4) and discharge (score 3).The untreated eye was unchanged.

The substance was regarded as corrosive to the eyes.

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:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

A study according to OECD TG 404 was performed to determine irritative/corrosive properties of the test item to the skin. The study was started with one rabbit. For the primary skin irritation, the test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of one previously shaven rabbit for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed after removal of the patches. Strong local changes were seen, the study was finished and the rabbit was sacrificed. Necrosis was seen at the application site directly after removal of the patches. No signs of pain or itching could be observed. Therefore, the test item is regarded as corrosive to the skin (reference 7.3.1 -1).

Eye irritation

A study according OECD TG 405 was conducted. According to the guideline the exposure of one animal is recommended if it is suspected that the test material might produce severe irritation. Therefore the study was started with one rabbit. For the primary eye irritation test, 0.1 g test material was applied into the conjunctival sac of the rabbit. The first examination of the eyes followed immediately after instillation. No signs of pain were observed. Strong local irritations were seen, the study was finished, and the rabbit was sacrificed. Immediately after instillation opacity (score 4) of the cornea was observed. The iris was not visible. The conjunctivae showed redness (score 3), chemosis (score 4) and discharge (score 3).The untreated eye was unchanged. The substance caused severe damage to the eyes (reference 7.3.2 -1).

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin irritation and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be classified for skin and eye corrosion Cat.1 (H314) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521. Sub-categorisation cannot be applied based on the available data.