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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

skin irritation (BASF internal Standard, 4h): not irritating (BASF, 1979)
skin irritation (Draize Test, 24 h): slightly irritating (BASF, 1979)
eye irritation (BASF internal Standard): irreversible damage after 8 days (BASF, 1979)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report
Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41, 1973
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
The animals were offered a standardized animal laboratory diet
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
The substance was not washed off after application
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Skin scales formation at the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: within 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
3.75
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
1.85
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
All animals showed slight erythema after treatment. Four out of six animals developed slight edema. After 8 days (intact skin) all animals showed scaling of the skin but no erythema or edema.
Other effects:
The skin findings were pathologically confirmed.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report
Principles of method if other than guideline:
according to Fed. Reg. 38, No. 1987, § 1500.42, 1973 (Draize test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
The animals were offered a standardized animal laboratory diet.
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
The test substance was not washed out.

SCORING SYSTEM: Draize Scale
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Cornea score after 8 days: 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Animal #1 developed iritis with a score of 1 after 8 days.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation
Following the experimental design according to Federal Register 38, No. 187, § 1500.41, S. 27019, 27. Sept. 1973 0.5 mL of a 45 % solution of the test substance with water was applied to the intact and abraded skin of six rabbits (BASF, 1979). The application to the intact skin resulted in slight irritation after 24 hours (4/6 slight erythema and oedema; 2/6 questionable erythema) and after 72 hours (3/6 questionable; 1/6 slight; 2/6 no erythema; 5/6 no oedema). After 8 days (intact skin) all animals showed scalling of the skin but no erythema or oedema.
For the abraded skin slight to severe irritation was observed after 24 hours (6/6 slight oedema; 1/6 slight erythema; 1/6 marked erythema; 4/6 severe erythema). After 72 hours all animals had developed severe erythema in the form of necrosis. Slight oedema was only observed in 1 out 6 animals after 72 hours. The erythema effects still existed after 8 days. No oedema was observed at the end of the study period. Based on the findings on the intact skin, the test substance is slightly skin irritating.

The skin irritation potential of the test substance was also assessed in a study comparable to OECD guideline 404 (BASF, 1979). 1 mL of the test substance was applied to the intact skin of two rabbits under an occlusive dressing for 4 hours. The test substance was washed off with water after the exposure time. No oedema was observed over the entire observation period (8 days). One animal developed very slight erythema which dissolved by the end of the observation period. According to the results of this study, the substance is not irritating to the intact skin of rabbits.

Eye irritation
Following the experimental design according to Federal Register 38, No. 187, § 1500.42, S. 27019, 27. Sept. 1973, 0.1 mL of the test substance was instilled in the conjunctival sac of six rabbits (BASF, 1979). The eyes were not washed after 24 hours of exposure. Animals were observed for 8 days. Irritation was scored by the method of Draize et al..
The application to the intact eye resulted in marked redness of the conjunctivae in all 6 animals lasting up to day 8. Slight to marked chemosis was observed in all animals but was reversible in 5/6 animals until day 8. Iritis was not observed in all animals. Two animals developed questionable symptoms after 24 hours which were resolved after 48 hours. Very slight symptoms of corneal opacity were observed in 3/6 animals which lasted up to the end of the observation period in two animals with increasing symptoms (marked opacity).
According to the above findings, the substance causes serious eye damage.


Justification for selection of skin irritation / corrosion endpoint:
scientifically acceptable study report

Justification for selection of eye irritation endpoint:
scientifically acceptable study report

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as eye damage cat. 1, H318 "Causes serious eye damage" under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.

The test substance showed a slight skin irritating potential, but does not need to be classified and labelled under Regulation (EC) No 1272/2008, as ammended for the seventh time in Regulation (EC) No 2015/1221.