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Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, GLP, K, rel. 1)

Eye irritation: not irritating (OECD 405, GLP, K, rel. 1)

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 1990-02-28 to 1990-03-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 404 (1981) and in compliance with GLP. 4. Initial and final body weights were not reported. However this was not considered to affect the reliability of this study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
body weights not reported
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarpoley, Cheshire
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet (e.g. ad libitum): Standard Rabbit Diet ad libitum (supplied by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): mean 42 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-02-22 To: 1990-03-03
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: the patch was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elsatic Bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with water dampened tissues
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD recommended scoring system
Irritation parameter:
erythema score
Basis:
animal: #1 and #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:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.
Other effects:
None

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

1 h

0/1/1

0/0/1

24 h

0/0/1

0/0/0

48 h

0/0/0$

0/0/0

72 h

0/0/0

0/0/0

Average 24h, 48h, 72h

0.0/0.0/0.33

0.0/0.0/0.0

Reversibility*)

c

-

Average time (day) for reversion**

48 h

 

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

$= Dryness

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material induced a slight irritation being reversible within 48 h.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the clipped skin of the dorsal surface of the trunk of 3 New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours.

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.

The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.33 for erythema and 0.0/0.0/0.0 for oedema.

Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.

Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

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 1989-02-10 to 1989-02-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 405 and 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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: M: 15 weeks; F: 16 weeks
- Weight at study initiation: M: 2.7 kg; F: 2.6-2.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From:1989-02-10 To: 1989-02-21
Vehicle:
other: undiluted or in Neantine
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Left eye: 0.1 g (undiluted) / Right eye: 0.1 mL (diluted into 30 % in Neantine)
Duration of treatment / exposure:
Eyes were not rinsed
Observation period (in vivo):
Eyes were observed 1, 24, 48, 72 hours and 7 days after administration
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:

SCORING SYSTEM: Draize scale according to the OECD test guideline No. 405

TOOL USED TO ASSESS SCORE: slit-lamp and diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #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, #2 and #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 and #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
See Table 7.3.2/1
Other effects:
none

Table 7.3.2/1: Mean irritant/corrosive response data of each animal at each observation time up to removal from the test

 

Score at time point / Reversibility

Cornea opacity(/4)

Iris

(/2)

Conjunctivae

Redness

(/3)

Chemosis

(/4)

1 h

0/0/0

0/0/0

2/2/2

1/0/1

24 h

0/0/0

0/0/0

1/1/2

0/0/1

48 h

0/0/0

0/0/0

0/0/2

0/0/1

72 h

0/0/0

0/0/0

0/0/1

0/0/0

Mean 24-48-72 hrs

0.0/0.0/0.0

0.0/0.0/0.0

0.33/0.33/1.67

0.00/0.00/0.67

Reversibility*)

-

-

c.

c.

Average time (unit) for reversion

 

 

7 days

72 hours

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of undiluted Fixambrene was instilled into the left eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit was instilled with 0.1 mL Fixambrene diluted at 30 % in Neantine. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

 

The calculated mean score for each individual lesion for each animal treated with undiluted Fixambrene within 3 scoring times (24, 48 and 72 h) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions.

The effects observed were all reversible within 7 days.

 

Under the test conditions, Fixambrene is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A key study was identified (Inveresk, 1990, rel 1). In this dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, undiluted test material was dermally applied on the skin of 3 rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours.

The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.33 for erythema and 0.0/0.0/0.0 for oedema. Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.

Under the test conditions, the test material is not considered as a skin irritant.

Eye irritation:

A key study was identified (RCC, 1989, rel. 1). In this eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of test material was instilled into the eye of 3 rabbit. The left eye of each rabbit was instilled with 0.1 mL test substance diluted at 30 % in Neantine. The eyes were not rinsed after instillation of test material. 

The calculated mean score for each individual lesion for each animal treated with undiluted test material within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions. The effects observed were fully reversible within 7 days.

Under the test conditions, the test material is not considered as irritating to eyes.

Justification for classification or non-classification

Harmonised classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP).

Self-classification:

Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.

No data was available on respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory tract irritation.