Registration Dossier

Administrative data

Description of key information

The test item is not considered to be irritating to skin according to OECD Guideline 404.

The test item is not considered to be irritating to eye according to OECD Guideline 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 February - 12 February 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
Charles River, Kißlegg
- Age at study initiation:
about 22 weeks
- Weight at study initiation:
2.95 - 3.48 kg
- Housing:
separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2
- Diet: ad libitum (Altromin Standard Diet TPF® 2113, pellets)
- Water: ad libitum (tap water)
- Acclimation period:
at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 22
- Humidity (%):
54 to 75
- Photoperiod (hrs dark / hrs light):
12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
1 hour, 24, 48, 72 hours after treatment and then daily up to day 8
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing:
none

SCORING SYSTEM:
according to OECD Guideline

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not considered to be irritating to eye.
Executive summary:

A Study according to OECD Guideline 405 was performed to investigate the test item regarding its eye irritation potential. To test for primary eye irritation, 0.1 g of the test material powder was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for another 7 days. No signs of irritation were observed in cornea and iris. The conjunctivae showed redness (score 1) and discharge (score 1) in all animals at the first reading. This is a common finding in the case of powder application. The untreated eyes were unchanged. Thus, the test item is not considered to be irritating to eye.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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

Based on the available data, the test item is not classified and labelled for skin and eye irritation according to Regulation (EC) No 1272/2008.