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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a primary skin and eye irritation study, no skin or eye irritating effects were observed in six Himalayan rabbits. This was further supported by two in vitro tests, concluding that the test substance is non corrosive to skin and eyes (BASF SE, 1999).

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:
1999-07-12 to 1999-07-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Weight at study initiation: 2.49 - 2.76 kg (only male animals tested)
- Housing: single housing in stainless steel wire mesh cages
- Diet: ad libitum, standard laboratory diet (Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 g (moistened with aqua bidest.)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks (2.5 x 2.5 cm)
- type of wrap used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize et al. (1965)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Only one animal developed very slight erythema at 24 and 48 hours. No edema was observed in any of the animals. Erythema was fully reversible within 72 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
1999-07-12 to 1999-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant 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:
(1992)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Weight at study initiation: 2.55 - 2.58 kg (only male animals tested)
- Housing: single housing in stainless steel wire mesh cages
- Diet: ad libitum, standard laboratory diet (Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL bulk volume (about 28 mg of the comminuted test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize et al. (1965)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a primary skin irritation test according to OECD guideline 404 and EU method B.4, 0.5 g test substance (moistened with aqua bidest.) was administered to the intact skin of three male Himalayan rabbits for 4 hours under semi-occlusive dressing (BASF SE, 18H0464/982240, 1999). Residual test substance was washed off with Lutrol and Lutrol/water (1:1) after the exposure period. Animals were then observed for 72 hours. Scoring was performed according to Draize et al. (1965). Skin readings were performed 1, 24, 48 and 72 hours after end of exposure period. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.

Only one animal showed very slight erythema at the 24 and 48 hour reading. Erythema was fully reversible within 72 hours after exposure. No edema was observed.

Under the test conditions chosen and considering the described transient and mild findings, the test substance does not give indication of an irritant property to the intact rabbit skin.

This result is further supported by an in vitro screening assay using the EpiDerm Corrosivity Test kit (BASF SE, 61H0464/982205, 1999). Two trials were performed. The percentage of viability of the test substance was 85 and 89 % percent, respectively, underlining that the test substance is not corrosive to the skin.

Eye irritation

In a primary eye irritation test according to OECD guideline 405 and EU method B.5, 0.1 mL of the test substance was installed into the conjunctival sac of the right eye of three young adult Himalayan rabbits (males) for 24 hours (BASF SE, 11H0464/982241, 1999). Eyes were washed with tap water. Animals were then observed for 14 days. Irritation was scored by the method of Draize et al (1965).

The average score (24 to 72 hours) for irritation was calculated to be 0.8 for corneal opacity, 0.2 for iris, 1.8 for conjunctival redness and 0.4 for chemosis. One animal exhibited suppuration and loss of corneal tissue 48 and 72 hours after application. These findings as well as other observed symptoms were fully reversible in all animals within 14 days after application.

According to the findings in this test, the test substance is considered slightly irritating. But the results do not fulfil the classification criteria according to CLP.

This result is further supported by an in vitro Hen's egg test on chorioallantoic membrane (HET-CAM) (BASF SE, 60H0464/982206, 1999). Three eggs were treated with the test substance and no hemorrhages, lysis and coagulation was seen up to 300 s after application of the test substance. An irritation index of 0 was determined. The test substance is therefore regarded as non-corrosive the eyes.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study.

Justification for selection of eye irritation endpoint:
GLP and guideline compliant study.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes. As a result the substance does not need to be classified and labelled for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221.