Registration Dossier

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
Study period:
08.04.2002 - 17.05.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age at study initiation: 9 – 11 weeks
- Weight at study initiation: about 2 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69 x 45 x 51 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary. Throughout the study each cage was identified by a colour coded label recording the study number, animal number and the details of treatment. This colour coding matched the corresponding colour coded formulation container.
- Diet (e.g. ad libitum): commercially available antibiotic free pelleted laboratory diet (AItromin MSK, Altromin, D-32770 Lage, Postfach 1120, Germany) ad libitum throughout the study.
- Water (e.g. ad libitum): Animals were offered drinking water supplied to each cage via water bottles
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%.
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 l 12

IN-LIFE DATES: From: To: 13.05.2002 - 17.05.2002
Type of coverage:
semiocclusive
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): with 1 ml sterile water

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: A 0.5 g aliquot of the supplied test item was reduced to a paste with 1.0 ml of sterile waterThe test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The gauze square was then placed onto the animal's skin with the test item in direct contact with the skin. A strip of aluminium foil was placed over the treated site and the whole assembly held
in place by encircling the trunk of the animal ith a length of elastic adhesive bandage, this forming a semi-occlusive barrier.The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Postexposure period: 72 h
- Removal of test substance: After a period of 4 hours, the adhesive bandage and gauze patch were removed from the treated site of each animal which was cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours after the end of the exposure period

Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation or other reaction was apparent on the treated skin of any animal.
Other effects:
Changes in body weight during the course of the study were not remarkable. There was no indication of a systemic effect of treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal irritation of 2-decyltetradecanoic acid was investigated in the rabbit. A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure period. No irritation was apparent following a 4 hour period of exposure to the substance. These results indicate that the test substance has no irritant effect on the skin of the rabbit.
Executive summary:

These results indicate that the test substance has no irritant effect on the skin of the rabbit.

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:
20.05. - 23.05.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69x45x51 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary. Throughout the study each cage was identified by a colour coded label recording the study number, animal number and the details of treatment. This colour coding matched the corresponding colour coded formulation container.
- Diet (e.g. ad libitum): a commercially available anti-biotic free pelleted laboratory diet (Altromin MSK, Altromin, D-32770, Lage Postfach 1120, Germany ad libitum throughout the study.
- Water (e.g. ad libitum): Animals were offered drinking water supplied to each cage via water bottles.
- Acclimation period: 10 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: 08.04.2002 - 23.05.2002
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye
Amount / concentration applied:
- Amount of substance instilled: 0.1 g into the right eye
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 g
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: the treated eye examined macroscopically for damage or irritation to the cornea, iris and conjunctivae using the untreated eye as a comparator control.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Slight redness was noted in 1 animal at the 1 hour examination. No reaction to treatment was observed at the 24, 48 or 72 hour post-dose examinations.
Other effects:
There was no indication of a systemic effect of treatment. Changes in body weight during the course of the study were not remarkable.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute eye irritation of the test substance was investigated in the rabbit. A 0.1 g aliquot of the substance was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after dosing. Slight redness was noted in 1 animal at the 1 hour examination. No irritation was apparent at the 24, 48 or 72 hour post-dose examinations. The results of this study indicated that the test item has no significant irritant effect in the eye.
Executive summary:

The results of this study indicated that the test item has no significant irritant effect in the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance is not skin irritating or eye irritating. Therefore the substance is not classified.