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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
GLP was not implemented at the date of study conduct.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.6 - 5.0 kg
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: paraffin oil
Controls:
other: animals were their own control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h exposure
Observation period:
10 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
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: 10 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, 7, and 10 days after patch removal; evaluation based on readings 1-4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.28
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
1.25
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.17
- irritation index: 1.25/8
Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch removal
evaluation based on readings 1-4

REVERSIBILITY: complete within 10 days
OTHER EFFECTS: eschar formation in the males (day 7)
Interpretation of results:
GHS criteria not met
Conclusions:
Classification : not irritating
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not implemented at the time of study conduct.
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:
TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.0 - 5.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Postexposure observation period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours 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:
24/48/72 h
Score:
1.67
Max. score:
110
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.33
- Conjunctivae (Chemosis): 0
- Overall irritation score: 1.67/110
REVERSIBILITY: complete within 72 hours
Interpretation of results:
GHS criteria not met
Conclusions:
Test Item is considered not irritating based to the availabel data according to OECD405 in rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

No reasons for classification (only limited effects observed)