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:
2 (reliable with restrictions)
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
male/female (each 3)
Type of coverage:
occlusive
Vehicle:
other: paraffin oil
Controls:
other: animals were their own control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h exposure
Observation period:
8 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.7 - 4.9 kg
- Number of animals: 3 males, 3 females
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g wetted with paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 8 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and
Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 6 and 8 days after patch
removal; evaluation based on readings 1-4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4h
Score:
1.28
Max. score:
8
Reversibility:
fully reversible within: 8d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4h
Score:
0.11
Max. score:
8
Reversibility:
fully reversible within: 8d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4h
Score:
1.29
Max. score:
8
Reversibility:
fully reversible within: 8d
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.11
- irritation index: 1.29/8
REVERSIBILITY: complete within 8 days
OTHER EFFECTS: eschar formation in 3 animals (day 6)

See also attached IUCLID4 dossier.

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification : not irritating
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
2 (reliable with restrictions)
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of 100% substance
Duration of treatment / exposure:
72h not rinsed
Observation period (in vivo):
6d
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.3 - 5.3 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Amount of substance instilled: 0.1 g
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6 days after
treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
3.75
Max. score:
110
Reversibility:
fully reversible within: 6d
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.94
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 3.75/110
REVERSIBILITY: complete in 6 days
OTHER EFFECTS: distinct redness in nictitating membranes of all animals
at 24 hours only
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

At the obserevd effect levels for skin and eye irritation there is no requirement for classification