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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (in vivo, similar to OECD 404): irreversible damage, corrosive based on effects observed in acute dermal toxicity study (expert judgement)

Eye irritation (in vivo, OECD 405): irreversible damage

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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 with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
no
Species:
rabbit
Strain:
other: White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Housing: only one animal was tested
- Diet (e.g. ad libitum): n.a.
- Water (e.g. ad libitum): n.a.
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
according to guideline

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.01 mL
Duration of treatment / exposure:
no washing
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: DRAIZE score, irritation index


TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72h
Score:
4
Max. score:
4
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: reading at 72 h only because of severe chemosis;
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24h -72h
Score:
3
Max. score:
3
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: hemorrhages
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h -72h
Score:
4
Max. score:
4
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: complete closure of eyelids due to severe swelling
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24h -72h
Max. score:
2
Reversibility:
not reversible
Remarks on result:
not determinable
Irritant / corrosive response data:
cornea score: reading was only at 72 h possible  because of severe chemosis
iris score: could not be evaluated because of severe chemosis
Other effects:
The animal was killed for ethical reasons at day 3. Severe damage of the eye.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A skin irritation study was performed similar to OECD guideline 404 (82-0009 -DKT, non-GLP). An amount of 2x 0.5 mL unchanged test substance (corresponds to 444 mg/kg bw) was applied on the skin of one rabbit for 40 min.

Skin effects could not be determined, because 10 minutes after application strong toxic respones was observed and the animal died after 40 minutes.

Based on the results of the study and the fact that in the dermal acute toxicity study (85 -0005 -DKT) redness, crusts and nose bleeding were observed 3 -40 minutes post-application, the substance is considered as corrosive.

 

Eye irritation:

The key study was performed in an eye irritation/corrosion study performed similar to OECD guideline 405 (86-0007 -DKT, non-GLP). 

A single White Russian rabbit received a single instillation of 0.01 mL test item into the eye. Washing of the treated eye was not done. The local irritation effects on the eye was scored according to Draize criteria 24-72 h post instillation. 

Corneal opacity of score 4 was observed 72 h after dosing. Conjunctival redness score 3 was observed 24 -72 hours post-application. Chemosis was scored 4 after 24 -72 hours. Iritis could not be evaluated becuase of severe chemosis. Hence, the animal was killed for ethical reasons on day 3. The experimental findings clearly show that the test item causes irreversible damage to the eye.

Justification for classification or non-classification

The available data on skin irritation/corrosion and acute dermal toxicity meet the criteria for classification as Skin Corrosive Cat. 1B (H314) according to Regulation (EC) No. 1272/2008 (CLP) and according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.

The available data on eye irritation/corrosion meet the criteria for classification as Eye Damage Cat. 1 (H318) according to Regulation (EC) No. 1272/2008 (CLP) and according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.