Registration Dossier

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).
- Respiration irritation: no information.

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 1994-04-26 to 1994-04-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 404 and in compliance with GLP.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
no data on the age of animals at study initiation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on the age of animals at study initiation
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Program (Inspection date: 1992-10-27)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hamshire.
- Age at study initiation: no data
- Weight at study initiation: 3.5, 3.7 and 3.9 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C.
- Humidity (%): 43-73 % with the exception of one occasion when the recorded relative humidity exceeded the protocol specific upper limit. This deviation is considered not to have affected the outcome of the study.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data
Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
3 females
Details on study design:
Initially, one animal was dosed in a preliminary screen to estimate the potential irritancy of the test article. Twenty four hours after patch removal a further 2 animals were dosed.

TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale (according to OECD guideline No. 404)
Irritation parameter:
erythema 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:
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:
One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time.
At the 24 hour observation, the treated skin site on all 3 animals was free of signs of irritation and remained so at the 48 and 72 hour examination.
Other effects:
None

Table 7.3.1/1: Irritant/corrosive response data for 3 animals 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

0.0 / 2.0 / 2.0

1.0 / 0.0 / 1.0

24 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

48 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

72 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

Average 24h, 48h, 72h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

Reversibility*)

-

-

Average time (day) for reversion**

-

-

 *) 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

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
Executive summary:

In a dermal irritation study performed similarly to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted ST 06 C 93 was dermally applied on the shaved skin of the dorsal surface of the trunk of 3 females 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 h after the removal of the patch.

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

One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours.

 

Therefore, ST 06 C 93 does not require a classification as irritant to the skin according to the 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 1994-05-31 to 1994-06-04
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:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on the age of animals at test initiation
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
no data on the age of animals at test initiation
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP compliance programme (inspection date: 1992-10-27)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hampshire
- Age at study initiation: no data
- Weight at study initiation: 3.2, 4.3 and 4.3 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC Stanrab, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C.
- Humidity (%): 39-64 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The eye was not rinsed after the instillation of the test item.
Observation period (in vivo):
Examination made 1, 24, 48 and 72 hours following instillation
Number of animals or in vitro replicates:
3 females
Details on study design:
One animal was dosed in a preliminary screen to assess the potential irritancy of the test material. At the 24 hour examination, a further 2 rabbits were dosed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

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

TOOL USED TO ASSESS SCORE: standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour)
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, #2 and #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, #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:
Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study.
Other effects:
none

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

 

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

0 / 0 / 0

1 / 0 / 1

24 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

48 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

72 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Average 24, 48, 72 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Reversibility*)

-

-

-

-

-

-

Average time (unit) for reversion

-

-

-

-

-

-

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

Interpretation of results:
GHS criteria not met
Conclusions:
The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions
Executive summary:

In an eye irritation study performed similarly to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted ST 06 C 93 was instilled into the right eye of 3 female New Zealand White Rabbits. The eyes were not rinsed after the instillation of the test item. The left eye of each rabbit served as control. 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. 

Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study.

The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions.

 

Under the test conditions, ST 06 C 93 is not classified as irritating to eyes according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and of 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 (Toxicol, 1994, rel. 1). This dermal irritation study was performed similarly to the OECD guideline No. 404, and in compliance with GLP. The mean individual scores calculated within 3 scoring times (24, 48 and 72 hours) for were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema. One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours. The test material does not require classification for skin irritation.

Eye irritation:

A key study was identified (Toxicol, 1994, rel. 1). This eye irritation study was performed similarly to the OECD guideline No. 405, and in compliance with GLP. Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study. The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions. The test material does not require classification for eye irritation.

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 data no self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.

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