SUMILIZER GP

Endpoint summary

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:

11 May - 03 Aug 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

test site area too small

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2008

Deviations:

yes

Remarks:

test site area 2.5 cm² instead of 6 cm², environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

step-wise testing was not performed but all animals were tested simultaneously, test site area 2.5 cm² instead of 6 cm², environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama LABES Co., Ltd. (Japan)
- Age at study initiation: 12 weeks
- Weight at dosing: 2.45 - 2.96 kg
- Housing: Individually, in aluminium cages (W450 x D550 x H350 mm).
- Diet: LRC-4 (Oriental Yeast Co., Ltd.), ca. 120 g/day
- Water: filtered tap water, ad libitum
- Acclimation period: 2 - 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): < 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: corn oil

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: moistened

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: The test substance was moistened in corn oil and spread on a 2.5 cm² lint patch and applied to the intact skin on the application site of the back of the animals.
- Type of wrap if used: The patch was held in contact with surgical tapes ("Blenderm" and "Micropore", 3M Co., Saint Paul, USA) and occluded with a pressure bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The treated areas were wiped with absorbent cotton dipped in acetone to clean off any remaining material.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Observations for skin irritations were made 1, 24, 48 and 72 h after patch removal. In addition, all animals were observed daily for clinical signs of toxicity.

SCORING SYSTEM:
- Method of calculation: Draize scoring

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

There were no skin irritation effects observed for any animal at any reading time point.

Other effects:

- Other adverse systemic effects: There were no clinical signs of toxicity observed for any animal during the whole study period.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified

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:

11 May - 03 Aug 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted in 1992

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted in 2008

Deviations:

yes

Remarks:

environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C), no stepwise testing performed

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

no treatment with analgesic or anaesthesia of the animal /animal eyes prior, during or after treatment; environmental conditions for animals: temperature outside the recommended range (22 ± 2 °C instead of 20 ± 3 °C), no stepwise testing performed

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kitayama LABES Co., Ltd. (Japan)
- Age at study initiation: 12 weeks
- Weight at dosing: 2.45 - 2.96 kg
- Housing: Individually, in aluminium cages (W450 x D550 x H350 mm).
- Diet: LRC-4 (Oriental Yeast Co., Ltd.), ca. 120 g/day
- Water: filtered tap water, ad libitum
- Acclimation period: 2 - 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): < 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL, corresponding to 0.029 g

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

There were no eye irritation reactions observed for any animal during the 72-h observation period.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: Not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritating potential of Sumilizer GP was assessed in an in vivo skin irritation study conducted under GLP conditions and in accordance with EU Method B.4 / OECD guideline 404. 0.5 mg of the test item was moistend in corn oil and applied to the clipped skin of three male New Zealand White rabbits. The skin was exposed for 4 h under semi-occlusive conditions. Local skin reactions were assessed according to the Draize scoring system 1, 24, 48 and 72 h post administration.

There was no indication of skin irritation observed for any animal at any reading time point. The mean erythema and edema scores over 24, 48 and 72 h were equal to 0 for all 3 animals. Based on the experimental results and under the conditions of the study, the test item is considered not-irritant to the skin.

 

Eye irritation

The test item was investigated for eye irritating effects in New Zealand White rabbits according to EU Method B.5 / OECD guideline 405 and compliant with GLP. The test was conducted with three male rabbits, for which a single test item dose of 0.1 mL (corresponding to approx. 0.029 g) was installed into the conjunctival sac of one eye, the other eye serving as control. The eyes were examined for local effects 1, 24, 48 and 72 h after test item instillation and evaluated according to Draize criteria.

There were no eye irritating effects observed in any animal at any reading time point. The mean irritation scores on corneal opacity, iritis, conjunctival redness and chemosis over 24, 48 and 72 h were zero for all 3 animals. Based on the experimental results and under the conditions of the study, the test item has no eye irritating potential.

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.