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Description of key information

Irritation:
- skin: corrosive
- eye: corrosive

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:
other: Acceptable, well documented study report which meets basic scientific principles
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
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
3 min and 1 h
Observation period:
8 days
Number of animals:
2 females
Details on study design:
TEST SITE
- Area of exposure: 1x1 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water/Lutrol (1:1)
- Time after start of exposure: 3 min and 1 h

Irritation parameter:
erythema score
Remarks:
, 3 min application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
, 3 min application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
, 1 h application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
, 1 h application
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing

Mean edema and erythema score from the 3 min and 1 h exposure after 3 min, 1 h, 24 h, 48 h and 8 days (animal1/animal2). Data for the 72 h time point was not recorded.

   3 min     1 h     24 h     48 h     8 days   
Exposure  edema  erythema  edema  erythema  edema  erythema  edema  erythema  edema  erythema
3 min exposure  0/0 1/1  -  - 0/0 1/1 0/0 1/1 0/0 0/0
1 h exposure  -  - 2/2 3/3 2/3 4/4 2/3 4/4 1/1 4/4

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

The application of the test substance for 3 min caused slight, reversible erythema.

The application for 1 h caused moderate to severe edema and severe erythema. After 24 h, parchment and leather-like necrosis were observed. The observed effects are considered as full thickness necrosis. Full thickness necrosis is considered to be an irreversible effect.

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is classified as corrosive to the skin according to Directive 67/548/EEC for acute dermal toxicity.
Executive summary:

Two animals were treated for 3 min or 1 h using occlusive conditions. An application site of 1x1 cm was covered with the liquid test substance. After the application time the skin was washed with water and water/Lutrol (1:1). The animals were observed for 8 days and skin changes were recorded daily.

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:
other: Acceptable publication which meets basic scientific principles. Results only as data tables.
Principles of method if other than guideline:
see details in remarks on material and methods
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
7
Max. score:
10
Reversibility:
not specified
Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the highly irritating eye effects observed the test substance has to be classified with "Risk of serious damage to eyes" in accordance with Directive 67/548/EEC (DSD).
Executive summary:

Eye injury in rabbits is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical, as detailed by Carpenter and Smyth. Grade 1 in the Table indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a primary skin irritation study with undiluted 2,6-dimethyl-morpholine (75 % cis / 25 % trans-mixture; CAS 6485-55-8) two animals were treated for 3 min or 1 h using occlusive conditions BASF AG, 1981; Val. 2). An application site of 1x1 cm was covered with the liquid test substance. After the application time the skin was washed with water and water/Lutrol (1:1). The animals were observed for 8 days and skin changes were recorded daily. The application of the test substance for 3 min caused slight, reversible erythema. The application for 1 h caused moderate to severe edema and severe erythema. After 24 h, parchment and leather-like necrosis were observed. The observed effects are considered as full thickness necrosis. Full thickness necrosis is considered to be an irreversible effect.

Only mild irritating effects to skin were found in a further study with 2,6- dimethylmorpholine (CAS 141-91-3) where only limited data is provided (Smyth et al. 1962; Val. 2).

 

Eye irritation:

Highly irritating to corrosive effects to eyes were found in a study with 2,6-dimethylmorpholine (CAS 141-91-3) where only limited data is provided (Smyth et al. 1962; Val. 2).

In general, as the test substance corrosive the skin, it can be expected to have a similar effect on the eyes, too.


Justification for selection of skin irritation / corrosion endpoint:
Most reliable study chosen.

Justification for selection of eye irritation endpoint:
Most reliable study chosen.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Despite the fact that not all available studies showed corrosive effects on the skin, the test substance has to has to be classified as Skin corrosive: Cat 1B: H314: Causes severe skin burns and eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and C: R34: Causes burns in accordance with Directive 67/548/EEC (DSD).

Based on the corrosive eye effects observed the test substance has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xi: R41: Risk of serious damage to eyes in accordance with Directive 67/548/EEC (DSD).