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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No data on the test item is available. With the read-across substances the following results were obtained:

Skin irritation: CAS 68583-51-7 not irritating

Eye irritation: CAS 68583-51-7 not irritating

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:
April 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: F .D .A . Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p.47.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
68583-51-7
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
no details available
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 mL test substance
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 h
Number of animals:
six
Details on study design:
TEST SITE
- Area of exposure: back
- Size: one inch
- Type of wrap: rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATION TIME POINTS
24 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize system
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
At no time during the experiment did the material under test cause any reaction on the rabbit back.
Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation was investigated on rabbits. At no time point during the experiment did the test item cause any reaction.
Executive summary:

In the test on skin irritation of the test item six New Zealand White rabbits were restrained in suitable stocks. Their backs were shaved with electric clippers and one side of each back abraded with a suitable abrading tool. Under a one squar inch patch, 0.5 mL of the test substance was introduced. The patches were kept in place with adhesive tape and the entire trunk of the animal wrapped with rubberised cloth for the entire 24 hour period of exposure. After 24 h the patches were removed and the resultant reactions evaluated according to the Draize system. Readings were made at 24 and 72 h and both intact and abraded areas taken into account. At no time during the experiment did the material under test cause any reaction on the rabbit back. It is concluded that, under the conditions of the experiment, the test item is innocuous.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Chapter 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: F.D.A. Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics 1959 p.49
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no details available
- Age at study initiation: adults
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed.
- Time after start of exposure: 4 seconds after instillation with 20 mL lukewarm water

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed and unwashed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: washed and unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed and unwashed
Irritant / corrosive response data:
The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris. Please refer to Tabel 1 for details.

Table 1: Details on results

 

 

 

Cornea

Iris

Conjunctivae

 

Animal

Day

Opacity

Area

Redness

Chemosis

Discharge

Unwashed

1

1

0

0

0

1

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

2

1

0

0

0

2

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

3

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

Washed

4

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

5

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

6

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritation was investigated on six rabbits. Only slight erythema of the conjunctivae were detected and failed to persist beyond 24 hours after administration.
Executive summary:

For the test on eye irritation six adult New Zealand white rabbits were used. A 0.1 ml sample of the test material was instilled into one eye of each rabbit, the contralateral eye remaining untreated as a control. In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed with 20 ml lukewarm water 4 seconds after instillation. Readings were made at 1, 2, 3, 4 and 7 days to assess the irritant effects on various parts of the eyes. These assessments were made according to the Draize scale. The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Chapter 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed and unwashed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: washed and unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
3
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: washed and unwashed
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on the test item is available. With the read-across substances the following results were obtained:

In the test on skin irritation of the read across substance CAS 68583-51-7 six New Zealand White rabbits were restrained in suitable stocks. Their backs were shaved with electric clippers and one side of each back abraded with a suitable abrading tool. Under a one inch patch, 0.5 mL of the test substance was introduced. The patches were kept in place with adhesive tape and the entire trunk of the animal wrapped with rubberised cloth for the entire 24 hour period of exposure. After 24 h the patches were removed and the resultant reactions evaluated according to the Draize system. Readings were made at 24 and 72 hr. and both intact and abraded areas taken into account. At no time during the experiment did the material under test cause any reaction on the rabbit back. It is concluded that, under the conditions of the experiment, the test item is innocuous.

For the test on eye irritation six adult New Zealand white rabbits were used. A 0.1 mL sample of the read across substance CAS 68583-51-7 was instilled into one eye of each rabbit, the contralateral eye remaining untreated as a control. In three rabbits the treated eye remained unwashed, in three rabbits the treated eyes were washed with 20 mL lukewarm water 4 seconds after instillation. Readings were made at 1, 2, 3, 4 and 7 days to assess the irritant effects on various parts of the eyes. These assessments were made according to the Draize scale. The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris.

Based on the results of the read across susbtance the test item is not irritant to eye or skin.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye and skin irritation, the test item is classified and labelled as not irritant to eye and skin according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.