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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: The susbtance was found to be not irritating to skin.

Eye irritation: The substance was found to cause serious eye damage.

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:
1990-11-27 to 1990-11-30
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:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,8 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:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

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 if used: 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
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 mL of the undiluted test material 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:
1990-12-04 to 1990-12-07
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:
1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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: 3.1 - 4.1 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: 0.1 mL

Duration of treatment / exposure:
single treatment, the eyes were washed out after 24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3 animals
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:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
Up to 72 hours p.a., conjunctivae of all animals were red and swollen, eyelids were half to fully closed. From 24 h p.a. onwards all animals exhibited a reddened iris. Clear-clourless to whitish discharge was observed. The animals were sacrificed 72 h p.a. due to severe signs of irritation.
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 and classified into category 1.
Executive summary:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application. Up to 72 hours p.a., conjunctivae of all animals were red and swollen, eyelids were half to fully closed. From 24 h p.a. onwards all animals exhibited a reddened iris. Clear-clourless to whitish discharge was observed. The animals were sacrificed 72 h p.a. due to severe signs of irritation. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

0.5 mL of the undiluted test material 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 irritation:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application. Up to 72 hours p.a., conjunctivae of all animals were red and swollen, eyelids were half to fully closed. From 24 h p.a. onwards all animals exhibited a reddened iris. Clear-clourless to whitish discharge was observed. The animals were sacrificed 72 h p.a. due to severe signs of irritation.

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.