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Diss Factsheets

Administrative data

Description of key information

The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.The test item (0.5 gpasted with 1.2 ml polyethylenglycol 400) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. No erythema or edema were observed at any time point (score 0).There was no indication of systemic toxicity.

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405.

Chemosis was observed in all three animals 1 h after application. The effect was fully reversible within 48 h. Conjunctival redness was observed in all three animals up to 72 h after application , reversible by seven days. Iridial effects were noted in one animal up to 24 h. Corneal opacity was not oberved in any animal.

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 01 NOV 1988 to 04 NOV 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404; EU method B4), in compliance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, breeding colony, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.4 kg
- Housing: individually
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum and 15 g hay/day
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylenglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1.2 ml polyethylenglycol 400.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster

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

SCORING SYSTEM: as in OECD TG 404 described, reading at 30-60 min, 24, 48 and 72 h after removal of test item.

Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Irritant / corrosive response data:
No effects (erythema or edema) were visible at any time point in all animals.
Other effects:
The treated skin was coloured yellow.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin when tested under the conditions of the OECD guideline 404.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.The test item (0.5 g pasted with 1.2 ml polyethylenglycol 400) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. No erythema or edema were observed at any time point (score 0). There was no indication of systemic toxicity.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
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 08 NOV 1988 to 15 NOV 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405; EU method B5), in compliance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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: Hoechst AG, breeding colony, Germany
- Age at study initiation: abour 3-5 months
- Weight at study initiation: 2.1 - 3.6 kg
- Housing: single
- Diet: mixed feed (Altromin 2123), ad libitum, and about 15 g hay daily
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
24 h
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): with physiologic saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM:
Scores were read 1, 24, 48 and 72 h after test substance application as well as after 7 days.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 and 72 h reading

Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2 and #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals #2 and #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
- no corneal effects were observed.
- iris scores for animal #1,2,3 after 1h: (0,1,0), after 24 h: (1,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
- conjunctivae redness scores for animal #1,2,3 after 1 h: (2,2,1), 24 h: (2,1,1), 48 h: (2,2,1), 72 h: (1,0,0) and 7 days: (0,0,0)
- chemosis scores for animals #1,2,3 after 1 h: (2,2,2), 24 h: (2,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
All effects were completely reversible within 7 days.
Other effects:
No other effects reported
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material is slightly irritating to the eyes when tested under the conditions of the OECD guideline 405. Chemosis was seen at 1 (all animals) and 24 h (one animal), being reversible within 48 h. Redness of the conjunctivae was also seen in all animals in the 1 h reading, being fully reversibly after 7 days. Animal #2 had an iris score of 1 in the 1 h reading, animal #1 in the 24 h reading. These effects were fully reversible within 48 h. No corneal effects were observed.

The effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405.

Chemosis was observed in all three animals 1 h after application. The effect was fully reversible within 48 h. Conjunctival redness was observed in all three animals up to 72 h after application , reversible by seven days. Iridial effects were noted in one animal up to 24 h. Corneal opacity was not oberved in any animal.

 

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification

The test item did not cause adversee effects after dermal or ocluar exposure in vivo.