Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance caused severe damage to the rabbit eye. Strong effects concerning cornea opacity, iris, conjunctivae redness and swelling were seen in all animals and none of these effects were reversible within 7 days. Only slight irritating effects on rabbit skin, which were lower than the classification threshold, were caused by the substance.

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:
February 8, 1982 - February 15, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(24 h exposure, occlusive treatment, observation period)
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: UFA Versuchsbetrieb Buehl, CH-5604 Hendschiken
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit foot, NAFAG, No. 814, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 days (scoring 24, 48 and 72 h and 4 and 7 days after application)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch covered with an impermeable material, fastened with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM:
- Evaluation according to the Draize Scoring System for abraded and intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Table 1: results for skin irritation (intact skin):

Observation time

Rabbit no.

1

2

3

4

5

6

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

Ery.

Edema

24 h

2

2

2

1

0

0

2

3

1

0

2

1

48 h

2

2

1

2

0

2

2

2

1

2

1

2

72 h

1

2

0

1

0

2

0

0

0

3

0

3

4 d

2

2

0

1

0

2

0

0

0

3

0

3

7 d

2

2

0

1

0

2

0

0

0

2

0

2

Mean value 24 + 48 + 72 h

1.67

2.00

1.00

1.33

0.00

1.33

1.33

1.67

0.67

1.67

1.00

2.00

Mean value 24 + 48 + 72 h all animals

0.95

1.67

-

-

-

-

-

-

-

-

-

-

Only the values for intact skin were taken in account for classification.

4/6 animals had an average edema score (24 - 72 h) > 1.5

Interpretation of results:
GHS criteria not met
Conclusions:
According to the EU CLP regulation the dermal reactions resulting from exposure to the test article are below the level of significance and therefore the substance does not need to be classified.
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:
February 8, 1982 - February 15, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, observation period 7 days)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: UFA Versuchsbetrieb Buehl, CH-5604 Hendschiken
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit foot, NAFAG, No. 814, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
one single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in 3/6 animals
- Time after start of exposure: 30 s after application

SCORING SYSTEM: evaluation according to the Draize Scoring System at day 1, 2, 3, 4 and 7

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed, score = 2 in all 3 animals (24/48/72 h)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed; score = 3 in all 3 animals (24/48/72 h)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed; score = 3 in all 3 animals (24/48/72 h)

Table 1: Results of eye irritation

 

Eye treatment

not rinsed

rinsed

Animal no.

1

2

3

4

5

6

24 h

Cornea

2

2

2

1

1

1

Area

4

4

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

2

3

2

Discharge

2

2

2

2

3

2

48 h

Cornea

2

3

2

1

1

1

Area

4

3

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

2

2

2

72 h

Cornea

2

3

2

1

2

2

Area

4

3

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

1

2

2

4 d

Cornea

2

3

2

1

3

3

Area

4

4

4

4

4

4

Iris

2

2

2

1

2

2

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

3

Discharge

2

2

2

0

1

2

7d

Cornea

2

4

3

2

3

4

Area

4

4

4

4

4

4

Iris

2

2

2

2

2

2

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

0

1

1

Mean value 24, 48, 72 h

Cornea

2.00

2.67

2.00

1.00

1.33

1.33

Iris

2.00

2.00

2.00

1.00

1.00

1.00

Conjunctiva

3.00

3.00

3.00

2.00

3.00

3.00

Chemosis

3.00

3.00

3.00

1.33

2.33

2.00

Only the data of the animals that were not rinsed were considered for classification as, according to OECD guideline 405, the eyes should not be washed within 24 h after application. In this study, the eyes were washed 30 s after application.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this experiment the test material was found to cause a marked irritation when applied to the rabbit eye mucosa.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In a primary dermal irritation study, performed using a method identical to that described in the Federal Register, Vol. 43, No. 163, August 22, 1978, 0.5 mL of the test substance (no data on purity) was applied under occlusive conditions to the intact and abraded skin of 6 Albino rabbits. Treatment was terminated 24 hours following application and the animals were observed for 7 days. Irritation was scored according to the Draize method 24, 48 and 72 hours and 4 days and 7 days after application. The animals had an average erythema score (24 h – 72 h) between 0 (1/6) and 1.67 (1/6) (maximal score = 4) and an average edema score (24 h – 72 h) between 1.33 (2/6) and 2.00 (2/6) (maximal score = 4). Only in 1/6 animals were the effects fully reversible within the observation period, but the tendency in the other animals pointed towards attenuation of the effects. It can be assumed that the effects would have been reversible within a larger observation period and/or conditions according to actual guidelines. Results from the abraded skin are not included in the final judgement for skin irritation of the test substance because of its lack of scientific justification and deviation from todays acceptable standardized procedures for the appraisal of skin irritation. In this study, the test substance is not a skin irritant (Ciba Geigy Ltd. 1982). This study is suitable for assessment of dermal irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline. The conditions are even harsher (occlusive, extended exposure) than that described by the actual OECD guideline.

 

Eye irritation

The eye irritation potential of the test substance (no data on purity) was determined in a procedure similar and equivalent to the Test Guideline OECD 405. 0.1 mL of the test substance was applied to the conjunctival sac of the left eye of each of 6 Albino rabbits. The other eye remained untreated and served as control. The eyes of 3 animals were rinsed approximately 30 seconds after application. Irritation was recorded after 24, 48 and 72 hours. Appraisal of eye irritation was performed according to the method of Draize. Average Draize scores (24, 48 and 72 hours) were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis. Average values (24 h – 72 h) of the 3 animals whose eyes were not rinsed for cornea were between 2 and 2.67 (maximal score = 4). Iris score were 2 (maximal score = 2) in all animals. The values for conjunctivae redness and chemosis were 3 in all animals (maximal score = 3 and 4, respectively). None of the effects was reversible within 7 days. Hence, in this study, the test substance causes irreversible damage to the eyes (Ciba Geigy Ltd. 1982). This study is suitable for assessment of eye irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline.

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 the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, classification for skin irritation is not warranted and "category 1" is warranted due to its eye damaging potential.