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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 05, 1982 to October 08, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not conducted under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Body weight: 2.3 - 2.6 kg
Temperature: 22 +/- 2°C
Humidity: 50 +/- 20%
Ligh/dark period: 12/12 hours
Feed and water: ad libitum
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
0.5, 1, 24, 48 and 72 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At 1 h slight edema (Grade 1) and slight to moderate erythema (Grade 2) was observed. Edema was no longer visible at the 24-hour evaluation. Erythema wa completely reversed after 72 hours.
Other effects:
Discoloration was observed until 24 h.
All signs of irritation were reversible within 72 h.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404. The clipped dorsal flank (ca. 20 cm2) of three New-Zealand white rabbits was exposed to 500 mg test substance (in the form of a yellow-brown powder of 48% purity) for 4 h under semi-occlusive conditions. At the end of the exposure period, the treated skin area was carefully cleaned. Skin irritation/corrosion was assessed 0.5, 1, 24, 48 and 72 h after bandage removal. Erythema (Grade 2 then 1) was observed in all animals for 24 h. Only one animal still showed mild erythema (Grade 1) at 48 h and there were no further observations at 72 h. Oedema occurred in all 3 animals at the 0.5 - 1 h time point but was no longer seen after that. The overall irritation index was calculated to be 1.0, the test substance was therefore considered to be slighly irritating to rabbit skin (Jung, 1982). Under the current evaluation system, the test substance is considered as not irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From March 16, 1976 to March 29, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Not conducted under GLP
Principles of method if other than guideline:
The clipped and scarified (on one side only) dorsal flanks (ca. 3 x 3 cm) of six SPF-Albino Himalayan rabbits, 1.5 - 2.0 kg bodyweight, were exposed to 0.5 ml of undiluted or 10% diluted test substance (in the form of a viscous liquid of 20% purity) for 24 h under occlusive conditions. The test substance was applied on a 2.5 x 2.5 cm gauze bandage held in place with tape. An occlusive 6-8 cm wide PVC strip was placed over the bandage, then covered by an elastic band which surrounded the animal. Skin irritation/corrosion was assessed at patch removal, then after 48 and 72 h. A dermal irritation index was calculated according to § 1500.41 of US FDA Federal Register 38, No. 138, 27.9.1973, p 27019.
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Remarks:
Albino
Details on test animals or test system and environmental conditions:
Body weight: 1.5-2.0 kg
Food and water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
one flank scarified, the other not
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10%
Duration of treatment / exposure:
24 h
Observation period:
Immediately after patch removal, the at 48 and 72 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h + 72 h
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was therefore considered to be not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance (in the form of a viscous liquid of 20% purity). The clipped and scarified (on one side only) dorsal flanks (ca. 3 x 3 cm) of six SPF-Albino Himalayan rabbits were exposed to 0.5 ml of undiluted or 10% diluted test substance for 24 h under occlusive conditions. Skin irritation/corrosion was assessed at patch removal, then after 48 and 72 h. No effects were observed in any of the animals (irritation index = 0), regardless of exposure (scarified/not scarified, pure/10% diluted). Under the study conditions, the test substance was therefore considered to be not irritating to rabbit skin (Hollander, 1976).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 05, 1982 to October 08, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not conducted under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: single
- Diet: EKRA Z 6000 ad libitum
- Water: tap water ad libitum
- Acclimation period: not applicable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 05 to 08 October 1982
Vehicle:
physiological saline
Remarks:
0.07 mL to form a paste
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg in the conjunctival sac of the left eye
Duration of treatment / exposure:
24 h (following this period, the eyes were flushed with warm physiological saline)
Observation period (in vivo):
1, 7, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
24 h before the application of the test substance, the eyes were instilled with a fluorescein solution (0.01%) and the eyes were examined by means of UV-light for corneal damages.
In addition corneal damage was investigated after 24 and 72 hours by fluorescein staining.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Two animals at 1 and 7h post - application exhibited conjunctival redness and swelling.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritating to rabbit eye.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 405. Three New-Zealand white rabbits received 100 mg of substance moistened with 0.07 ml saline solution in the conjunctival sac of the left eye. The right eye remained untreated and served as negative control. After 24 h of exposure, the treated eye was gently rinsed with 37°C saline solution and evaluated for effects on iris, cornea and conjunctiva after 1, 7, 24, 48 and 72 h. (Jung, 1982). There were no changes in the iris or cornea of any of the rabbits throughout the study. Conjunctival redness and chemosis (Grade 1 or 2) occurred in two animals 1 and 7 hours after treatment; the symptoms had resolved at the 24 h time point. No other effects were recorded. Under the study conditions, the test substance was therefore considered to be not irritating to rabbit eyes (Jung, 1982).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From March 16, 1976 to March 29, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not conducted according to GLP
Qualifier:
according to guideline
Guideline:
other: US FDA Federal Register Vol. 38, No. 187, p 27019, 1973
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
Body weight: 1.5-2.0 kg
Food and water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Chemosis and discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered not to be irritating to rabbit eyes
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 405. Six SPF-Albino Himalayan rabbits received 0.1 ml of undiluted substance in the conjunctival sac of the left eye. The right eye remained untreated and served as negative control. After 1, 7, 24, 48 and 72 h, the eyes were evaluated for effects on iris, cornea and conjunctiva. There were no changes in the iris or cornea of any of the rabbits throughout the study. Conjunctival redness (Grade 2) occurred in a single animal at 1 h but the symptoms had resolved at the 7 h time point. Under the study conditions, the test substance was therefore considered not irritating to rabbit eyes (Hollander, 1976).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404. The clipped dorsal flank (ca. 20 cm2) of three New-Zealand white rabbits was exposed to 500 mg test substance (in the form of a yellow-brown powder of 48% purity) for 4 h under semi-occlusive conditions. At the end of the exposure period, the treated skin area was carefully cleaned. Skin irritation/corrosion was assessed 0.5, 1, 24, 48 and 72 h after bandage removal. Erythema (Grade 2 then 1) was observed in all animals for 24 h. Only one animal still showed mild erythema (Grade 1) at 48 h and there were no further observations at 72 h. Oedema occurred in all 3 animals at the 0.5 - 1 h time point but was no longer seen after that. The overall irritation index was calculated to be 1.0, the test substance was therefore considered to be slightly irritating to rabbit skin (Jung, 1982). Under the current classification and labelling regulation, the test substance is not irritating to skin.

A study was conducted to determine the skin irritation/corrosion potential of the test substance (in the form of a viscous liquid of 20% purity). The clipped and scarified (on one side only) dorsal flanks (ca. 3 x 3 cm) of six SPF-Albino Himalayan rabbits were exposed to 0.5 ml of undiluted or 10% diluted test substance for 24 h under occlusive conditions. Skin irritation/corrosion was assessed at patch removal, then after 48 and 72 h. No effects were observed in any of the animals (irritation index = 0), regardless of exposure (scarified/not scarified, pure/10% diluted). Under the study conditions, the test substance was therefore considered to be not irritating to rabbit skin (Hollander, 1976).

The results of the above studies do not trigger a classification for skin irritation according to CLP (EC 1272/2008) criteria.

Eye irritation

A study was conducted to determine the eye irritation potential of the test substance (in the form of a yellow-brown powder of 48% purity) according to OECD Guideline 405. Three New-Zealand white rabbits received 100 mg of substance diluted in 0.07 ml saline solution in the conjunctival sac of the left eye. The right eye remained untreated and served as negative control. After 24 h of exposure, the treated eye was gently rinsed with 37°C saline solution and evaluated for effects on iris, cornea and conjunctiva after 1, 7, 24, 48 and 72 h. (Jung, 1982). There were no changes in the iris or cornea of any of the rabbits throughout the study. Conjunctival redness and chemosis (Grade 1 or 2) occurred in two animals but the symptoms had resolved at the 24 h time point. No other effects were recorded. Under the study conditions, the test substance was therefore considered to be not irritating to rabbit eyes (Jung, 1982).

A study was conducted to determine the eye irritation potential of the test substance ( in the form of a viscous liquid of 20% purity) according to OECD Guideline 405. Six

SPF-Albino Himalayan rabbits received 0.1 ml of undiluted substance in the conjunctival sac of the left eye. The right eye remained untreated and served as negative control. After 1, 7, 24, 48 and 72 h, the eyes were evaluated for effects on iris, cornea and conjunctiva. There were no changes in the iris or cornea of any of the rabbits throughout the study. Conjunctival redness (Grade 2) occurred in a single animal at 1 h but the symptoms had resolved at the 7 h time point. Under the study conditions, the test substance was therefore considered not irritating to rabbit eyes (Hollander, 1976).

The results of the above studies do not trigger a classification for eye irritation according to CLP (EC 1272/2008) criteria.

Justification for classification or non-classification

Based on the results of in vivo studies, no classification for skin and eye irritation is required for the test substance according to CLP (EC 1272/2008) criteria.