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Diss Factsheets

Administrative data

Description of key information

The substance is corrosive and causes severe damage of the skin already 3 minutes after application and severe damage to the eyes.

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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.4 kg
- Housing:individually in stainless stell cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1 °C
- Humidity (%): 60+/-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 31.07. To: 06.08.1984
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of the test product to approx. 6 cm² skin area.
Duration of treatment / exposure:
Skin reaction was assessed and recorded at 1 and 24 h after removal of the dressing and after 48 h and 72 h and after 6 days.
Observation period:
6 days
Number of animals:
3 males, 3 females
Irritation parameter:
erythema score
Remarks:
males
Basis:
mean
Time point:
other: 1 h
Score:
2.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Remarks:
males
Basis:
mean
Time point:
24 h
Score:
3.67
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
Irritation parameter:
erythema score
Remarks:
males
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
Irritation parameter:
erythema score
Remarks:
males
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: induration of the area of application; severe necrosis with vesiculation over the entire area of application; edges of the area of application dark red (1 animal)
Irritation parameter:
erythema score
Remarks:
males
Basis:
mean
Time point:
other: 6 days
Reversibility:
not specified
Remarks on result:
other: severe necrosis with vesiculation over the entire area of application
Irritation parameter:
erythema score
Remarks:
females
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Remarks:
females
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
Irritation parameter:
erythema score
Remarks:
females
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
Irritation parameter:
erythema score
Remarks:
females
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: edges of the area of application dark red (2 animals); induration of the area of application; severe necrosis with vesiculation over the entire area of application
Irritation parameter:
erythema score
Remarks:
females
Basis:
mean
Time point:
other: 6 days
Reversibility:
not specified
Remarks on result:
other: severe necrosis with vesiculation over the entire area of application
Irritation parameter:
edema score
Remarks:
males
Basis:
mean
Time point:
other: 1 h
Score:
2.67
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
males
Basis:
mean
Time point:
24 h
Score:
3.67
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
males
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
males
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
males
Basis:
mean
Time point:
other: 6 days
Reversibility:
not specified
Remarks on result:
other: open weeping wounds, bleeding cracks
Irritation parameter:
edema score
Remarks:
females
Basis:
mean
Time point:
other: 1 h
Score:
1.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
females
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
females
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
females
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
females
Basis:
mean
Time point:
other: 6 days
Reversibility:
not specified
Remarks on result:
other: open weeping wounds, bleeding cracks

After 6 days, the experiment was terminated due to severe effects.

The irritation index was 6.13/8 and hence a single dermal application of 0.5 ml of the product is very irritant for male and female rabbits.

Evaluation in accordance with Appendix VI of the Sixth Amendment (79/831/EEC):

Erythema: x = 4.0

Oedema: x = 2.78

There was necrosis formation after an exposure time of only 3 minutes.

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
The substance is skin corrosive.
Executive summary:

The substance is skin corrosive.

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:
1984
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)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): K4 Alleinfutter für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 31.07. To: 06.08.1984
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of the product
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Time of assessment: 1 h, 24 h, 48 h, 72 h, 6 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 h with warm physiological solution


SCORING SYSTEM: according to Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
20
Max. score:
20
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
36.67
Max. score:
40
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
40
Max. score:
60
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
50
Max. score:
60
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 6 days
Score:
51.67
Max. score:
60
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: The iris could not be assessed because of the severe chemosis. Since all the animals showed damage to the iris after chemosis had disappeared, the iris is assessed at "1" at and after the first hour.
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (1 animal)
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (3 animals)
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (3 animals)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 6 days
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (2 animals), circumcorneal injection (2 animals)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
18
Max. score:
18
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
19.33
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Corrosion of the mucosa, dissolution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
18.67
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
17.67
Max. score:
18
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution (2 animals)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
3.2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.

All the animals held their heads on one side up to 48 h after application (in each case toward the treated side). Because of the severity of the damage, the investigation was terminated after the 5th assessment, and the animals were sacrificed.

Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance causes irreversible effects on the eyes.
Executive summary:

The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.

Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 6 small white Russian, Chbb-SPF rabbits.

With reference to the reported scores and the severity of effects the test item has to be classified as corrosive according (H 314 causes severe skin burns and eye damage) to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). As necrosis was already obvious after 3 min of exposure a classification as Cat. 1A is recommended.

There is one reliable study available on the eye irritancy potential. The test item was tested for its eye irritant properties in 6 small white Russian rabbits (3males and 3 females). Because of the severity of the damage, the investigation was terminated after the 5th assessment (6 days after end of exposure), and the animals were sacrificed. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.

With reference to the reported scores and severity of effects the test substance has to be classified as severely irritant to the eyes (H 318 causes serious eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Justification for classification or non-classification

With reference to the reported scores and the severity of effects the test item has to be classified as skin corrosive Cat. 1A and as causing serious eye damage (H 314 causes severe skin burns and eye damage) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).