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Diss Factsheets

Administrative data

Description of key information

Skin irritation/skin corrosion: No corrosive or irritant properties 
Eye irritation: No corrosive or irritant properties

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:
November 27, 1997 - July 03, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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: Charles River GmbH, Sulzfeld
- Age at study initiation: no data available
- Weight at study initiation:
animal #1: 2623 g (at the start) ; 2677g (at conclusion of the test)
animal #2: 2613g (at the start); 2665g (at conclusion of the test)
animal l#3: 2863g (at the start), 2954g (at conclusion of the test)
- Housing: Altromin Type S8/15, granulated soft wood bedding, Batch 181297
- Diet (e.g. ad libitum): Altromin 2123, standard diet for rabbits, Batch 220198/1404
- Water (e.g. ad libitum): tap water (municipal supply), Makrolon bottles, daily change
- Acclimation period: 6 weeks before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 35-45%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light is set to give a cycle of 12 hours light and 12 hours dark, light from 6.30 a.m. - 6.30 p.m.

IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch with the test article on it was moistened with distilled water and then applied
Duration of treatment / exposure:
The administration was performed on January 15, 1998, 8.39 - 8.41 a.m.
Exposition period: 4 hours
Observation period:
Animals were examined for sings of erythema and oedema and the response scored at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 4x5 cm on the left and on the right side of the spine (one area was used as control)
- % coverage: 2.5x3.5 cm (gauze patch, two layers)
- Type of wrap if used:overed with aluminium foil (3x4 cm) which was held in contact with the skin by occlusvie dressing (Lohmann GmbH & Co. , Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Grading of skin reaction:
Erythema and Eschar formation value
No erythema .............................................................................0
Very slight erytheina (barely perceptible) ........................... 1
Well defined erythema .............................................................2
Moderate to severe erythema................................................ 3
Severe erythema (beet redness) to eschar formation
preventing grading of erythema............................................4

Oedema formation
No oedema ...............................................................................0
Very slight oedema (barely perceptible)..............................1
Slight oedema (edges of area well defined by definite raising....2
Moderate oedema (raised approximately 1 millimetre) .............. 3
Severe oedema (raised more than 1 millimetre
and extending beyond area of exposure)......................................4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
see "results and discussions"
Other effects:
The control skin areas of the animals didn`t show any alterations at any observation time.
The treated skin areas showed only a slight erythema one hour after patch removal in two animals.
Other signs of irritation were not observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The application of 0.5g of the test item to shaved dorsal area of trunk of albino rabbits caused only a slight erythema on hour after patch removal in two animals. No systemic toxic effects were observed.

Executive summary:

The acute dermal irritation/corrosion of the test item was tested in three albino rabbits.

The test article was applied in a single dose of 0.5 g to a shaved dorsal area of trunk and covered with agauze patch and aluminium foil which was held in contact with the skin by an occlusive dressing. Exposure duration was 4 hours. Thereafter residual substance was removed using water.

Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal.

Only a slight erythema was observed one hour after patch removal in two animals. No animal died or showed clinical signs in the course of testing.

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:
July 1998 - September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute 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: Charles River Wiga GmbH
- Age at study initiation:
- Weight at study initiation:
animal #1: 3138 g (at the start); 3155g (at conclusion of the test)
animal #2: 3768g (at the start); 3852 g (at conclusion of the test)
animal #3: 3832g (at the start): 3957g (at conclusion of the test)
- Housing: Cages of stainless stell with bottom grid of oval steel and with tub for faeces, dimenstions of the cages: 50x55x40 cm
Bedding: Altromin Type S8/15, granulated soft wood bedding, Batch 240798
- Diet (ad libitum): Altromin 2123, standard diet for rabbits, Batch 071198/1307
- Water (ad libitum): tap water (municipal supply), Makrolon bottles, changed daily
- Acclimation period: the animals wre housed approx. 4 month before administration to the testing facility

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 50-70%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 houer ligth and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning).
The conjunctivae, cornea and iris of the eyes were examined at 1, 24, 48 and 72 hours and from day 4 until day 7 after instillation by means of a hand slit-lamp (Heine Optotechnik).
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed out with distilled water
- Time after start of exposure: 24 hours

SCORING SYSTEM:
see table 1

TOOL USED TO ASSESS SCORE:
hand-slit lamp (Heine Optotechnik)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days

In the treated eye a briefly serous lacrimation was observed in all animals one hour after instillation. The control eyes of the animals showed no alterations at any observation time.

The Cornea of the treated eye showed a slight opacity in one animal only one hour after instillation. The iris was not affected.

The conjunctivae of the treated eyes were slightly red in one animal and clearly red in two animals one hour after instillation and clearly red 24 hours after instillation in all three animals. This clear redness continued in all animals until 48 hours after instillation. Then the redness faded in all animals and a redness was not more observed on day 7. One hour after instillation a clear swelling of conjunctivae was observed in two animals and a swelling with lids about half closed was observed in one animal. This swelling faded quickly and 24 hours (in two animals) or 48 hours (in one animal) after instillation a swelling was not more observed. 7 days after instillation no signs of irritation were observed.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is non-irritant to the eye.
Executive summary:

The acute eye irritation/corrosion of the test item was tested in three albino rabbits. The test article was applied at a single dose of 0.1 g to one of the eyes in each animal. The eyes were washed out 24 hours after instillation of the test article using distilled water. The untreated eye was used for control. The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48 and 72 hoursand from day 4 until day 7 after instillation of the test article.

The instillation of the test article caused a clear redness for 48 hours and a briefly clear swelling of the conjunctivae in all 3 animals.

The cornea was only slight affected and the iris was not affected.

No Signs of systemic effects of the test article were observed in the course of testing.

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

Respiratory irritation

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

Additional information

Based on the available information, the test substance is not irritating to skin, eyes and the respiratory tract. In in vivo-study with albino rabbits no acute dermal irritation/corrosion or eye irritations were detected. Moreover no signs of systemic effects were observed.

The determination of the pH-value of the test substance in a range between 9 and 10, also doesn't contribute to an indication of irritating or corrosive properties.

These findings were supported by an occupational medical assessment. There was no indication of an increase of skin problems caused by exposure to the substance, e.g. corrosive/ irritation effects.

Justification for classification or non-classification

Due to the test results, the test item needs not to be classified irritating/corrosive.