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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance is corrosive to the skin and detoriates eye mucous membranes. (BASF, 1977)

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
Study period:
1976 - 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
BASF Test, see details in remarks on material and methods
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 3.42 kg; male: 2.75 kg




Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 1 mL
Duration of treatment / exposure:
20 h
Observation period:
2 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
Irritation parameter:
other: Necrosis in all 2 animals after 1 min, 5 min, 15 min or 20 hours treatment
Basis:
mean
Time point:
other: 24 h
Reversibility:
not reversible
Remarks on result:
other: Both animals died 2 days after exposure.
Irritant / corrosive response data:
Based on the necrosis observed 24 hours after 1 min, 5 min, 15 min or 20 min treatment, the test substance is corrosive to the rabbit skin and should be classified according to the EU (R35) and to GHS (Cat 1A).
Other effects:
All 2 animals died within 2 days.

Both animals died 2 days after exposure. Based on corrosive effects, the substance has to be judged as corrosive to skin.

Interpretation of results:
corrosive
Remarks:
Migrated information Cat 1A Criteria used for interpretation of results: OECD GHS
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
Study period:
1976 - 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
0.05 ml of intilled test substance
Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.71 kg; male: 3.32 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 mL
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: similar to OECD

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h-8 days
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h-8 days
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h-24h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
The test substance caused irreversible effects under the conditions of the study.
Other effects:
Necrosis, staphyloma were also observable and not reversible.

 Time  Animal Erythema  Opacity  Chemosis
 1h  No 1  -  3  2
   No 2  -  2  1
 24 h  No 1  2  3  2
   No 2  2  3  2
 8 days  No 1  -  -  -
   No 2  2  4  2

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

With regard to the key study, the test substance was identified as corrosive dependent on the applied criteria. The corrosive potential was measured by applying 1 mL undiluted test substance: two rabbits were treated for 1, 5, 15 min or 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. Both animals died 2 days after exposure. Based on corrosive effects, the substance has to be judged as corrosive to skin (BASF, 1977).

 

Eye irritation

Eye injury in rabbits was reported in an in-house study classified as key study (BASF, 1977), one drop of undiluted test substance in rabbit eyes caused irreversible effects of the eye mucous membranes within 24 h (oedema, opacity, staphyloma and necrosis), even after 1 h (oedema, opacity).


Justification for selection of skin irritation / corrosion endpoint:
Only one study available with the test substance. Estimated Klimisch Rating: 2

Justification for selection of eye irritation endpoint:
Only one study available with the test substance. Estimated Klimisch Rating: 2

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results for skin irritation (corrosive) and for eye irritation, the test substance is classified for skin irritation/corrosion as follows:


 


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 (CLP). As a result the substance is considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014, as follows:


Cat. 1A, H314, causes severe skin burns and eye damage; Cat. 1, H318, causes serious eye damage.