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Diss Factsheets

Administrative data

Description of key information

The test item (0.5 g), moistened with water, was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for twenty four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.


Therefore, it is concluded that the test item is not irritating to skin.


Test material was subject to a test of eye irritancy according to OECD guideline 405. 30 mg (0.1 mL) of substance were applied to one eye of three animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited conjunctivitis. All animals were free of ocular irritation by 24 hours. No other effects could be observed in any animal. Therefore, it is concluded that the test item is not irritating to 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:
From 19 MAY 2011 to 23 JUN 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, in compliance with GLP
Qualifier:
according to guideline
Guideline:
other: Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DNA Rabbitry, Elk River, MN, USA
- Age at study initiation: young adults
- Weight at study initiation: 2.3 kg (female), 2.7 kg (female), 2.2 kg (female)
- Housing: individual boxes
- Diet: standard laboratory diet, ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- According to AAALAC International recommendations for rabbits
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: control: wetted patch; positive control: 2.5% and 5% sodium lauryl sulfate
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): a not further quantified amount of tap water was used to moisten the test item
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): diluted alcohol
- Time after start of exposure: 24 h

SCORING SYSTEM: in accordance with OECD TG 404, reading at 1, 24, 48 and 72 h after removal of test item
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h after removal of patches
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h after removal of patches
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Irritant / corrosive response data:
- No erythema or oedema were observed at any time point.
Other effects:
- no clinical signs recorded
- A red coloration was noted on the treated areas which made it difficult to score for erythema
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin under the test conditions described above. Skin exposure was longer (24 h) than recommended in OECD TG 404 (4 h). No dermal reactions, neither erythema nor edema, were observed.
Executive summary:

The primary skin irritation potential of the test item was investigated according to Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization.

The test item (0.5 g), moistened with water, was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for twenty four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.

Therefore, it is concluded that the test item is not irritating to skin.

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 06 Jun 2011 to 16 JUN 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405), in compliance with GLP
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: Robinson Services, Inc.
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031 ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL (0.03 g)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
2 females, 1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: in accordance with OECD TG 405.
Scores were read 1, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 h reading
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritant / corrosive response data:
Iris, and cornea scores were 0 for all three animals at all time points (1, 24, 48 and 72 h). Conjunctiva redness and chemosis scores were also 0 for all three animals at 24, 48 and 72 h reading. Only one female showed slight chemosis at the 1 h reading (score 1, animal 2) and two animals (one male and one female, animal 1 and 2, respectively) showed slight redness (score 1 and 2, respectively) at the 1 hour reading. Slight discharge (score 2, 2, 1 in animal #1, 2, 3, respectively) was observed in all animals at the 1 h reading. All effects were fully reversible withing 24 hours.
Other effects:
All animals appeared active and healthy during the study. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to the eyes under the test conditions of OECD 405.
Executive summary:

Test material was subject to a test of eye irritancy according to OECD guideline 405. 30 mg (0.1 mL) of substance were applied to one eye of three animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited conjunctivitis. All animals were free of ocular irritation by 24 hours. No other effects could be observed in any animal. Therefore, it is concluded that the test item is not irritating to eyes.

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, as no adverse effects were observed.