Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): not irritating

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:
05 - 12 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2015
Deviations:
yes
Remarks:
age of animals at study initiation not reported, one test with 3 animals performed instead of initial + confirmatory test, observation period 7 instead of 14 days
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: not reported, adult animals
- Weight at study initiation: 2.8 - 3.4 kg
- Housing: individually in wire type III upright cages
- Diet: ssniff K4 standard diet (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 2 weeks in quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 05 May 1987 To: 12 May 1987
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed "Hypoallergen" dressing (Beiersdorf No. 2342) fastened with elastic adhesive tape (Fixomull Stretch Klebevlies, Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing: exposed skin area was cleaned with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72h and 7d

SCORING SYSTEM:
- Method of calculation: Draize scoring system described in OECD TG 404
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One animal was scored for erythema and escharosis formation grade 1 (slight, barely perceptible redness) at the 1h time point. The finding was reversible within 24h. No further effects were seen.
Other effects:
None.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The study is in accordance to OECD TG 404, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did not induce skin irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.
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:
05 - 12 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2020
Deviations:
yes
Remarks:
diet not provided ad libitum, no anaesthetics used, observation period only 7 days
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: not reported, adult animals
- Weight at study initiation: 3.1 - 3.3 kg
- Housing: individual in wire type III upright cages
- Diet: standard diet "ssniff K4" (Versuchstierdiäten GmbH, Soest, Germany), approximately 120 g per animal and day
- Water: tap water, ad libitum
- Acclimation period: at least 14 days in the quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 05 May 1987 To: 12 May 1987
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL, equivalent of approximately 60 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: physiological saline solution
- Time after start of exposure: 24h

SCORING SYSTEM: DRAIZE criteria as stated in OECD TG 405

TOOL USED TO ASSESS SCORE: optical instruments and one drop of a 1% fluorescein solution
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
At the 1h time point one animal was scored for conjunctivae redness grade 2 and chemosis grade 1 and another animal was scored for conjunctivae redness grade 1. All findings were reversible within 24 h. No further effects were noticed.
Other effects:
None.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The study is in accordance to OECD TG 405, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did not induce irritation to the eye of rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritation is required.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The irritancy potential of the test substance to skin was evaluated according to OECD guideline 404 and in compliance with GLP (M-028272-01-1). In this study, 0.5 g test substance (purity 94.2%) was applied to the shaved skin of the left or right flank each of three New Zealand White rabbits under a semi-occlusive dressing for 4 h. The untreated skin served as control. The test item did not induce irritant or corrosive effects determined 1, 24, 48 and 72 h after removal of the dressing despite a very slight erythema and escharosis (both scored with grade 1) observed in one test animal 1 h after removal of the dressing. No other cutaneous reactions were observed until the end of the study. Mean scores evaluated over 24, 48 and 72 h were 0.0 for erythema and edema for each animal.

 In conclusion, the test substance did not exhibit skin irritating properties in the conducted study.

 

Eye irritation

A GLP-conform eye irritation/corrosion study was performed according to OECD Guideline 405 to evaluate the eye irritancy potential of the test substance (M-028278-01-1). A single dose of 0.1 mL (equivalent to approx. 60 mg) test substance (94.2% purity) was instilled to the eye of each of three New Zealand White rabbits. After exposure (24 h), the test substance was washed off the eyes with physiological saline solution. The test item induced slight conjunctival redness in 2/3 test animals scored 1 to 2 at reading point 1 h. Moreover, chemosis was observed in 1/3 animals at the same reading time point graded with 1. Full reversibility occurred within 24 hours. No further ocular reactions were observed until the end of the study. Mean scores evaluated over 24, 48 and 72 h were 0.0 for chemosis, conjunctivae, iris and cornea opacity for each animal.

In conclusion, the test substance did not exhibit eye irritating properties in the conducted study.

Justification for classification or non-classification

Reliable study data revealed that the test item is not irritating to the skin or the eye of rabbit. Thus, according to the CLP Regulation (EC) No. 1272/2008, no classification is required for the present compound regarding skin and eye irritation.