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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

skin irritation: not irritating based on acute dermal study in rabbits

eye irritation: not irritating, Draize test

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs, and cosmetics", (1959) , US Association of Food and Drug Officials (AFDO)
Principles of method if other than guideline:
Draize-Test
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: different suppliers in Switzerland
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: individual housing in wire cages (55x48x44 cm)
- Diet: NAFAG No. 84 rabbit food, ad libitum
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55-60
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
substance was not washed out
Observation period (in vivo):
after 24 hrs and 2, 3, 4 days
Number of animals or in vitro replicates:
6 (males)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing

SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(for each animal)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
(for each animal)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(for each animal)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
/ for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritations were seen in the cornea, iris or conjunctivae at any time point and animal.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the present experimental conditions no irritant effects were seen when the test substance was introduced into the rabbit eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

No study of skin irritation is available. In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted because an acute toxicity study by dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw).

Eye irritation:

In a primary eye irritation study, 0.1 g of test substance (no vehicle used) was instilled into the conjunctival sac of New Zealand White rabbits (6 males) without washing. Animals then were observed for 4 days. Irritation was scored by the method of Draize "Appraisal of the safety of chemicals in foods, drugs, and cosmetics", 1959, US Association of Food and Drug Officials (AFDO). No irritating effects to the cornea, iris or conjunctivae could be seen. In this study, substance is not an eye irritant.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation or corrosion of skin and eye under Regulation (EC) No. 1272/2008.