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
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)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chr. Fred Leuschner & Co., Löhndorf/Post Wankendorf, Germany
- Sex: males
- Age at study initiation: approx. 6 month
- Weight at study initiation: 2.4 - 2.9 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: at least 20 days
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as a control.
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 h
Observation period:
Scores were taken 60 min. after patch removal, and after 24, 48, 72 hours. Skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application.
Number of animals:
3 males
Details on study design:
STUDY DESIGN
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. For the duration of exposure the animals were kept in comfortable restrainers.

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: 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
- After the 4-hour exposure period the patch was removed.
- Washing (if done): not reported

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
other: 24, 48 and 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.67
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.
Executive summary:

In a study according to OECD TG 404 the test item was applied for 4 hours under semiocclusive dressings to the intact shaved skin of 3 male rabbits. Skin irritation was assessed after 1, 24, 48, and 72 hours using the Draize scale. Two rabbits showed a very slight erythema (grade 1) 24 and 48 hours after exposure with full reversibility after 72 hours. No systemic intolerance reactions were observed.

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:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chr. Fred Leuschner & Co., Löhndorf/Post Wankendorf
- Sex: males
- Age at study initiation: approx. 4.5-5 month
- Weight at study initiation: 2.0-2.2 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: at least 20 days
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye, which remained untreated, served as control.
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
After administration of the test substance into the conjunctival sac the lids were gently held together for about one second in order to prevent loss of the test material. No rinsing of the eyes was reported.
Observation period (in vivo):
Eye irritation was scored 1, 24, 48, 72 hours after administration and until the changes have completely subsided, however for not more than 21 days after application.
Number of animals or in vitro replicates:
3 males
Details on study design:
STUDY DESIGN
After gently pulling the lower lid away from the eyeball 100 µl test substance were administered into the conjunctival sac of the right eye of the rabbits.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE:
The eyes were examined ophthalmoscopically with a slit lamp prior to and after the administration. 24 hours after administration the eyes were treated additionally with fluorescein and examined.
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Other effects:
All animals showed a transparent film on the cornea (probably substance) until 24 hours after instillation. There were no systemic intolerance reactions.

"ENGLISH"

All animals showed a transparent film on the cornea

until 24 hours after instillation.

There were no systemic intolerance reactions.
Executive summary:

The test item was instilled into the conjunctival sac of the right eye of 3 male rabbits in a study according to OECD TG 405. Eye irritation was assessed using the Draize scale.

The cornea, iris and conjunctivae were not affected by instillation of the test compound. Only a transparent film, consisted probably of test compound, could be observed on the cornea up to 24 hours after exposure. No systemic intolerance reactions were reported.

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

Respiratory irritation

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

Additional information

In a skin irritation/corrosion study according to OECD TG 404 the substance showed an erythema grade 1 in 2/3 rabbits at 24 and 48 hours after exposure. The effect was fully resolved within 72 hours.

Cornea, iris and conjunctivae (redness and chemosis) were not affected after instillation of the test substance in a study according to OECD TG 405 in rabbits.

The substance indicated a low upper respiratory tract irritation potential in an acute aerosol inhalation study (cp. chapter Acute toxicity: inhalation).


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

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

Justification for classification or non-classification

No classification is required for skin or eye irritation/corrosion according to Regulation (EC) No 1272/2008, Annex I.

No classification is required for respiratory tract irritation according to Regulation (EC) No 1272/2008, Annex I, because the low vapour pressure of the substance prevents inhalative exposure, and the result of the available acute inhalation study with exposure to a highly respirable aerosol at the targeted limit concentration of 5000 mg/m³ (gravimetrical concentration 4923 mg/m³) did only lead to a mild upper respiratory tract irritation potential.