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Diss Factsheets

Administrative data

Description of key information

Skin irritation, OECD 404, rabbit: not irritating 
Eye irritation, OECD 405, rabbit: 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:
08 - 11 Mar 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Current version adopted in 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Guideline in place during study conduct: adopted in 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
Adopted in 1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 25 - 26)
Version / remarks:
Adopted in 1985
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 3 - 5 months
- Body weight at study initiation: 2.4 - 2.5 kg
- Housing: individually in separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g daily
- Water: tap water in drinking water quality, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Mar 1994 To: 11 Mar 1994
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Polyethylene glycol 400
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.35 mL
- Concentration: 0.5 g of the test substance were moistened with 0.35 mL polyethylene glycol 400
Duration of treatment / exposure:
4 h
Observation period:
Examinations of the skin took place 30 - 60 min, and 24, 48, and 72 h after removal of the patch.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The moistened test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Beiersdorf AG, Hamburg, Germany). The plaster was fixed to the prepared skin area and then covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with warm tap water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30 - 60 min, and 24, 48, and 72 h after removal of the patch

SCORING SYSTEM:
- Method of calculation: Erythema, eschar formation, and oedema were evaluated numerically according to the Draize scoring system.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance caused no dermal reactions in any of the test animals throughout the observation period.
Other effects:
No clinical signs of systemic toxicity were observed during the observation period.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
Based on the results of the present study, the test substance is considered to be non-irritating to the skin of rabbits.
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:
15 - 22 Feb 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Current version adopted in 2017 and corrected in 2020
Deviations:
yes
Remarks:
No pretreatment with a systemic analgesic and no induction of appropriate topical anesthesia.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Guideline in place during study conduct: adopted in 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
Adopted in 1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 23 - 24)
Version / remarks:
Adopted in 1985
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 3 - 5 months
- Body weight at study initiation: 3.4 - 3.6 kg
- Housing: individually in separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g daily
- Water: tap water in drinking water quality, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 Feb 1994 To: 22 Feb 1994
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Reading time points: 1, 24, 48, and 72 h and 7 days
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with physiological saline at approx. 37 °C
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At the 1 h reading time point 2/3 rabbits displayed inflammation of the iris (grade 1 of max. 2). In addition, in all 3 animals conjunctival reddening (grade 1 or 2 of max. 3), chemosis (grade 1 of max. 4) and discharge (grade 2 of max. 3) were observed. At the 24 and 48 h reading time points, inflammation of the iris (grade 1) was still evident in animal #2, only. Conjunctival reddening was seen in animal #1 (grade 1) after 24 h and in animal #2 after 24 (grade 2), 48 (grade 2), and 72 h (grade 1). In animal #2 conjunctival chemosis as well as discharge were noted after 24 (grade 2) and 48 h (grade 1). Chemosis (grade 1) was still detected 72 h post administration. In animal #1 and #3 irritating effects were less pronounced than in animal #2 and fully reversible within 48 h. In animal #2 effects were fully reversible within 7 days.
Other effects:
No clinical signs of systemic toxicity were observed during the study.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
Based on the results of the present study, the test substance has no eye irritation potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is one GLP-conform OECD 404 guideline study available, assessing the irritating effects of the test substance to the skin (M-133267-01-1, 1994). The test was performed in 3 female New Zealand White rabbits which were exposed for 4 h to 0.5 g of the test substance under semiocclusive conditions. The skin irritation effects were scored at reading time points 1, 24, 48, and 72 h. No dermal reactions were caused by the test substance in any of the test animals during the 72-h observation period. In addition, no clinical signs of systemic toxicity were observed throughout the test.

 

The irritating effects of the test substance to the eyes were assessed in a GLP study performed according to OECD guideline 405 (M-133142-01-1, 1994). The left eye of three female New Zealand White rabbits was treated with 0.1 g of the test substance and rinsed after 24 h. Observations were conducted 1, 24, 48, and 72 h after removal of the test substance. At the 1-h reading time point 2/3 rabbits displayed inflammation of the iris (grade 1). In addition, in all 3 animals conjunctival reddening (grade 1 or 2), chemosis (grade 1) and discharge (grade 2) were evident. At the 24- and 48-h reading time point inflammation of the iris (grade 1) was still evident in animal #2, only. Conjunctival reddening was seen in animal #1 (grade 1) after 24 h and in animal #2 after 24 h (grade 2), 48 h (grade 2) and 72 h (grade 1). In animal #2 conjunctival chemosis as well as discharge were noted after 24 h (grade 2) and 48 h (grade 1). Chemosis (grade 1) was still detected 72 h post administration. In conclusion, irritating effects if any were less pronounced in animal #1 and 3 than in animal #2 and fully reversible within 48 h. In animal #2 effects were fully reversible within 7 days. No clinical signs of systemic toxicity were observed during the study.

Justification for classification or non-classification

The available data on skin irritation/corrosion and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.