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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
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 30, 1993 to December 03, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
See 'Principles of method if other than guideline'
Principles of method if other than guideline:
Body weights were not recorded. Unknown substance purity.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: not stated
- Weight at study initiation: 3.5 - 4.2 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: acclimation took place but acclimation period not stated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not diluted

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25mm x 25 mm
- % coverage: 100
- Type of wrap if used: test substance was applied under a gauze pad. Treatment site was covered with 'Elastoplast' elastic adhesive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There were no signs of toxicity or ill health in any rabbit during the observation period.
No dermal response to treatment was observed in any animal during the observation period.
Interpretation of results:
not irritating
Conclusions:
Under the study conditions, no reactions were observed following a single semi-occlusive application of the test substance to intact rabbit skin for four hours.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 ml of the test substance and observed for four days. Under the study conditions, no reactions were observed following a single semi-occlusive application of the test substance to intact rabbit skin for four hours (Parcell, 1994).

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

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:
From December 06, 1993 to December 20, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK) Ltd., Petersfield, England and Harlan UK, Oxon England
- Age at study initiation: not stated
- Weight at study initiation: 3.2 - 3.6 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: acclimation took place, but acclimation period not mentioned


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the other untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
The test substance was not washed from the treated eye.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 1 d
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 1 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Corneal opacities developed in three animals. Transient irridial inflammation was seen in one animal on one occasion only. A crimson or beefy red colouration of the conjunctivae was seen in all three animals, accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed.
The eyes were normal 7 days after instillation.
Interpretation of results:
irritating
Conclusions:
Under the study conditions, instillation of the test substance into the rabbit eye elicited corneal opacification, irridial inflammation and well-defined to moderate conjunctival irritation.
Executive summary:

A study was conducted to determine the corneal damage potential by the test substance according to EU Method B.5. Three rabbits were administered a single ocular dose of 0.1 ml of the test substance and observed for 7 days after instillation. Under the study conditions, instillation of the test substance into the rabbit eye elicited corneal opacification, irridial inflammation and well-defined to moderate conjunctival irritation (Parcell, 1998).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A study was conducted to determine the skin irritation potential of the test substance to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were applied a single dermal dose of 0.5 mL of the test substance and observed for 7 d. No skin reactions were observed following a single semi-occlusive application of the test substance to intact rabbit skin. Under the study conditions, the test substance was not considered to be irritating to rabbit skin (Parcell, 1994).

Eye irritation:

A study was conducted to determine the eye irritation potential by the test substance according to EU Method B.5. Three rabbits were administered a single ocular dose of 0.1 mL of the test substance and observed for 7 d after instillation. Instillation of the test substance into the rabbit eye elicited corneal opacification, irridial inflammation and well-defined to moderate conjunctival irritation. Under the study conditions, the test substance was considered to be irritating to rabbit eye (Parcell, 1998).

Justification for classification or non-classification

Based on the results of the in vivo skin irritation study, the substance does not warrant classification for skin irritation according to EU CLP (1272/2008/EC) criteria.

Considering the results of the in vivo eye irritation study, the substance is considered to be irritating to eyes and warrants a classification as Eye Irrit. 2 (H319: Causes serious eye irritation according to EU CLP (1272/2008/EC) criteria.