Registration Dossier

Administrative data

Description of key information

Application of 95% pure substance onto skin of test animals did not induce erythema or edema (according OECD guideline 404). Treatment of rabbits with material of unknown purity caused strong skin effects. It cannot be excluded that formation of erythema and edema resulted from additives of the test material. The test compound is therefore not considered to be irritating to skin. Installation of the material into rabbits eyes caused transient, slight conjunctival effects which resolved within 3 days. The material is not considered to bear an eye irritating potential.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): The test article was applied moistened with tap water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: surgical gauze covered with aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD Guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
Other effects:
In the area of application no discoloration of the skin was observed which could be related to effects of the test article.
The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Interpretation of results:
GHS criteria not met
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:
Eyes not washed out
Observation period (in vivo):
1-, 24-, 48- and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp and diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0.53
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
After 1 hour of treatment a redness and chemosis score of 2 was found in all animals. After 24 hours the chemosis was fully reversible and a mean conjunctival redness score of 1.3 (2/1/1) was found. After 48 hours only one animal showed a conjunctival redness score of 1 which was reversed after 72 hours. In the area of application no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. The body weight gain of all rabbits was similar.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Several studies were conducted to examine the skin irritation potential of the test item. In the key study performed according to OECD guideline 404, 0.5g of the test material (unchanged, 95% purity) were applied onto skin of 3 female rabbits for 4h under occlusive conditions. Effects were scored 1, 24, 48 and 72h after treatment. The substance did not induce edema or erythema. Mortality or clinical signs were also not observed (RCC, 1984). Additionally, three further studies are available. Material (Weston-XP or Weston-MDW) of unknown purity was applied onto intact or abraded skin of rabbits for 4h or 24h, respectively, under occlusive conditions. Effects on skin were scored up to 72h after treatment. Strong skin effects were recorded in these studies. The material Weston-XP 1452, used in one of the studies, is known to contain propanolamine. No substance information or data on analytical purity were mentioned in the other two study reports. Thus, it cannot be excluded that formation of erythema and edema after treatment with Weston-XP or Weston-MDW resulted from additives of the test material. The test compound itself is therefore not considered to be irritating to skin.

Eye irritation

An OECD guideline conform study was performed to examine the eye irritation potential of the test substance (RCC, 1984). 0.1g of unchanged material (95% purity) was installed into one eye each of three male rabbits. The eyes were not rinsed and effects were scored 1, 24, 48 and 72h after installation. The compound caused slight, transient conjunctival effects which were reversible within 72h. The material is not considered to bear an eye irritating potential.

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 classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.