Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Endpoint summary

Description of key information

In vivo skin irritation (OECD 404): Not irritating

In vivo eye irritation (OECD 405): Not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 March 2002 - 22 March 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An in vivo study was performed at 2002.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1997

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Albino rabbits (Chbb:HM)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: stock Chbb:HM(SPF) - Littlerussian, BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: no

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not indicated

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Ethanol/Diethylphthalate 1:1

Controls:

yes, concurrent vehicle

Amount / concentration applied:

0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle.
0.5 mL of the test substance or vehicle was applied.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: adhesive Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 1 hour, 24 hours, 48 hours and 72 hours after termination of exposure.

SCORING SYSTEM: according to the scale shown in table 1 and 2 ('Any other information on materials and methods, incl. tables').

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

1, 24, 48 and 72 hours after the termination of exposure none of the animals showed skin reactions.

Interpretation of results:

other: Not a skin irritant

Remarks:

According to EU CLP (EC. No. 1272/2008 and its amendments).

Conclusions:

Under the experimental conditions described in this report, no skin irritation was observed in rabbits after exposure to the substance.

Executive summary:

In this study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (EtOH/DEP, vehicle), 1%, 10%, 25%, 50% were tested with vehicle and 100% (v/v) was used undiluted. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant and does not need to be classified for skin irritation according to Regulation (EC) No. 1272/2008 and its amendments.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 April 2002 - 12 April 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In vivo information of 2002 is used for the assessment of the eye irritation.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1997

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: albino female rabbits of the stock Chbb:GM(SPF) - Littlerussian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: no

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature: 20°C ± 3°C
- Humidity: 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not indicated

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal three more rabbits were included in the study.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
After rinsing with 20 ml 0.9 % sodium chloride solution the eyes were examined again using UVlight to detect possible corneal damage.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

- One hour after the application of the test article all animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal were observed in one animal.
- 24 hours after the application of the test article two animals showed some conjunctival vessels definitely injected and a swelling above normal. Some conjunctival vessels definitely injected were observed in the third animal, whereas the fourth animal did not show any signs of eye irritation.
- 48 and 72 hours after the application of the test article all animals were free of any signs of eye irritation.

Interpretation of results:

other: Not an eye irritant.

Remarks:

In accordance Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

Based on the results of an eye irritation study, performed according to OECD 405 guideline and under GLP, the substance is considered not to be an eye irritant.

Executive summary:

A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant and does not need to be classified according to Regulation (EC) No. 1272/2008 and its amendments.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin corrosion: the substance is not corrosive in absence of skin and eye irritation.

Skin irritation:

In a study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle were tested. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant.

Eye irritation:

A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant.

Justification for classification or non-classification

Based on the results, the substance does not need to be classified for skin corrosion, skin irritation and eye irritation according to EU CLP (EC no. 1272/2008 and its amendments).