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Diss Factsheets

Administrative data

Description of key information

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: Study meets generally accepted scientific principles, acceptable for assessment: non-GLP, no data on purity of test substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG, Extertal, Germany
- Mean weight at study initiation: 2.7 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated opposite flank served as control
Amount / concentration applied:
500 µL
Duration of treatment / exposure:
4 hours
Observation period:
Examinations were terminated after 7 days, since all changes had completely subsided then.
Number of animals:
3
Details on study design:
TEST SITE
24 hours before testing fur was shorn with an electric clipper on both sides of the trunk.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test site was covered with a gauze patch, which was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 4 hours exposure period the patch was removed. Washing was done with water or olive oil.


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score: 1.7
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 1 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 1.3
Executive summary:

An acute dermal irritation/corrosion test was conducted according to OECD TG 404. In this study the substance elicited a very slight erythema and a very slight up to moderate oedema on 3/3 rabbits after 24, 48 and 72 hours (Mean scores at time points 24, 48, and 72 h: 0.8 for erythema, 1.2 for oedema). All effects were fully reversible after 7 days at the latest.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment: non-GLP, no data on purity of test substance.
Qualifier:
according 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
- Sex: male
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG, Extertal, Germany
- Mean weight at study initiation: 2.7 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The left untreated eye surved as control
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
The eye-lids were gently held together for about one second in order to prevent loss of the test compound. The eye was not rinsed after substance-application.
Observation period (in vivo):
Examinations were terminated after 7 days, since all changes had completely subsided then.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was not rinsed after substance-application.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: For the 24 hours score fluorescein was used. The evaluation was carried out with the aid of an ophthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score: 0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Executive summary:

An acute eye irritation/corrosion Test was conducted according to OECD TG 405. Only very slight conjunctival irritation was observed after 24, 48 and 72 hours (mean scores at time points 24, 48, and 72 h: cornea: 0, iris: 0, conjunctivae redness: 0.3, chemosis: 0.6). All effects were fully reversible after 7 days at the latest.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

When tested in a skin irritation/corrosion study according to OECD TG 404 the test substance elicited a very slight erythema and a very slight up to moderate oedema on 3/3 rabbits after 24, 48 and 72 hours (Mean scores at time points 24, 48, and 72 h: 0.8 for erythema, 1.2 for oedema). All effects were fully reversible after 7 days at the latest.

For assessment of eye irritation/corrosion a study according to OECD TG 405 is available. In this study very slight conjunctival irritation was observed after 24, 48 and 72 hours (mean scores at time points 24, 48, and 72 h: cornea: 0, iris: 0, conjunctivae redness: 0.3, chemosis: 0.6). All effects were fully reversible after 7 days at the latest.

The substance was proven to be respiratory irritating based on acute and repeated dose studies. For example, in a pulmonary irritant potency study rats showed signs suggestive of respiratory tract irritation at concentrations of 18.5 mg/m³ and above (cp. endpoint summary of chapter Acute Toxicity). The NOAEL of this study was considered to be 2.8 mg/m³ with respect to pulmonary irritation.

Additionally, a repeated 4 weeks-inhalation toxicity study according to OECD TG 412 revealed changes that were all related to portal-of-entry, local irritant effects (i.e. changes of larynx, airways, and alveoli; see chapter Repeated dose toxicity: inhalation; report AT06241, Bayer AG, 2010).


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Effects on respiratory irritation: irritating

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for skin and eye irritation/corrosion.

According to Regulation (EC) No 1272/2008, Annex I, classification as STOT SE 3 (H335: May cause respiratory irritation) is warranted.