Registration Dossier

Administrative data

Description of key information

Skin irritation: The substance was not irritating to the rabbits' skin.

Eye irritation: The substance caused serious eye damage in the in vivo study conducted with one rabbit.

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:
1990-10-16 to 1990-10-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D 271


Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.7 - 3.6 kg
- Housing: single
- Diet: ad libitum, Altromin 2123
- Water: ad libitum, deionized water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg pasted with 0.02 mL NaCl (0.9 %)

Duration of treatment / exposure:
4 h
Observation period:
readings were conducted 30-60 min, 24, 48 and 72 h after removal of the test substance
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal, appr. 25 cm^2
- Type of wrap: cellulose patch covered by a semiocclusive patch

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with lukewarm water
- Time after start of exposure: directly after removal of the patch ( 4h)

OBSERVATION TIME POINTS
30-60 min, 24, 48 and 72 h

SCORING SYSTEM:
5 graded scale (Draize)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were detected.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not irritating to skin in this in vivo study.
Executive summary:

0.5 mg of the test material, pasted with 0.02 mL of NaCl (0.9%), was applied to the clipped skin of three New Zealand White rabbits for 4 hours under semiocclusive dressing. After removal of the patches the test sites were washed with lukewarm water. Skin findings were scored 30-60 min, 24 h, 48 h and 72 h after removal of the test substance. As a result, no signs of irritation (edema oder erythema) were found on the tested skin sites. Therefore it was concluded that the tested substance is not irritating to skin.

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:
1990-10-23 to 1990-10-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D271
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123), hay
- Water: ad libitum (deionised, chlorated water)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:
single treatment, the eye was washed out after 24 hours with physiological saline
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
1 animal
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
24 h up to 7 days p.a. the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test item is considered to cause serious eye damage in the rabbits' eye.
Executive summary:

The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 100 mg of the test item was placed into the conjunctival sac of the left eye. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. From 24 h up to 7 days after treatment the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching. The animal was sacrificed on day 7. Based on these findings the test item was considered to cause serious eye damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin (OECD 404):

0.5 mg of the test material, pasted with 0.02 mL of NaCl (0.9%), was applied to the clipped skin of three New Zealand White rabbits for 4 hours under semiocclusive dressing. After removal of the patches the test sites were washed with lukewarm water. Skin findings were scored 30-60 min, 24 h, 48 h and 72 h after removal of the test substance. As a result, no signs of irritation (edema oder erythema) were found on the tested skin sites. Therefore it was concluded that the tested substance is not irritating to skin.

Eye irriation (OECD 405):

The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 100 mg of the test item was placed into the conjunctival sac of the left eye. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. From 24 h up to 7 days after treatment the animal exhibited a swollen and reddened conjunctiva and a reddened iris. Eyelids were more than halfly closed. Clear-clourless to whitish discharge was observed. On day 7, the cornea surface appeared uneven and the conjunctiva was partly detaching. The animal was sacrificed on day 7. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008 (CLP). As a result the substance is not considered to be classified for skin irritation but classified for eye irritation into category 1 (H318: causes serious eye damage) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.