Registration Dossier

Administrative data

Description of key information

Based on the results obtained from testing the substance was considered not irritating to skin and eyes.

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:
1990-11-5 to 1990-11-8
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same 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:
other: New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: male : 14 weeks, females: 15 weeks
- Weight at study initiation: male : 2.2 kg, females: 2.7 - 2.9 kg
- Housing:
- Diet: Pelleted standard Kliba 341, Batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g creme formulation containing 5 % (w/w) Panthenol

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 ( 1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 6cm²
- Coverage: 3 cm x 3 cm surgical gauze, covered by semi-occlusive dressing

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

SCORING SYSTEM:
OECD/GHS
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
no. 90; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
no. 91; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
no. 92; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
no. 90; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
no. 91; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
no. 92; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Clinical signs and viability/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
- Irritation: The test item showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
- Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Body weights: With the exception of female no. 92 which showed slight loss of weight during acclimatization the body weight gain of all rabbits was similar.
Other effects:
None.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irrtation/corrosive effect occurred on the skin of any animal at measuring interval.
Executive summary:

The test item was investigated for primary skin irritation in a study with rabbits in a 4-hour semi-occlusive application according to OECD guideline 404 and EU method B.4. The test article was applied undiluted in a dose of 0.5 g to the clipped dorsal skin of one male and two female New Zealand White rabbits. The exposure duration was 4 hours under a semi-occlusive wrapping. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the numerical scoring system according to the guidelines. The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.

No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect occurred on the skin of any animal at measuring interval.

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:
1990-11-20 to 1990-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987.
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fuellinsdorf
- Age at study initiation: male : 12 weeks, females: 12 weeks
- Weight at study initiation: male : 2.4 kg, females: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, Batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland) ad libitum
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 40-70 %
- Air changes (per hr): 10-15
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g creme formulation containing 5 % (w/w) Panthenol

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : No


SCORING SYSTEM:
OECD/GHS
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
no. 96; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
no. 97; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
no. 98; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
no. 96; male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
no. 97; female
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
no. 98; female
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
no. 96; male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
no. 97; female
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
no. 98; female
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
no. 96; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
no. 97; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
no. 98; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
None.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No Irritation/corrosion was observed at any of the measuring intervals.
Executive summary:

The test item was investigated for eye irritation/corrosion properties with three New Zealand White rabbits in a GLP and guideline study according to OECD guideline 405/EU method B.5. When administered neat into the conjunctival sac of the rabbit eye, the test item caused conjunctival injection disappearing within 24 hours. This reaction was characterized by a primary irritation score of 0.25, which indicates that the test article can be classified as non irritating for the rabbit eye. Based on this experimental result it can be assumed that short-lasting occasional or accidental contamination of the human eye with the substance will not be accompanied by risk for human health.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Irritation / corrosion

Based on the results obtained in the key study, a creme formulation containing 5 % of the test item was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect occurred on the skin of any animal at measuring interval. In a supporting study application of the undiluted test substance to the skin of the back and ear of White Vienna rabbits under occlusion produced signs of irritation only after prolonged exposure. Based on the results of these tests, the substance has to be classified as not irritating to the skin.

 

Eye irritation

When administered neat into the conjunctival sac of the rabbit eye, a creme formulation containing 5 % of the test item caused conjunctival injection disappearing within 24 hours. This reaction was characterized by a primary irritation score of 0.25, which indicates that the test article can be classified as non irritating for the rabbit eye. Based on this experimental result it can be assumed that short-lasting occasional or accidental contamination of the human eye with the substance will not be accompanied by risk for human health. In a supporting study fifty microlitres of the undiluted test substance were instilled into one eye of each of 2 rabbits. For control purpose, pysiological saline was instilled into the other eye. The eyes were not washed. Animals were observed for 8 days. Slight irritation of the cornea was observed. The eyes were normal after 2 days.

Based on these results, the test substance was not irritating to the eyes.


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

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

Justification for classification or non-classification

Based on the results obtained from testing the substance was not classified and labeled acoording to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).