Soybean oil, epoxidized, acrylate

Endpoint summary

Description of key information

The test substance did not show skin and eye irritancy in two well-conducted in vivo studies.

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:

January 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD guideline No. 404 and under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Albino rabbits of stiock Mol:Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week

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

IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Number of animals:

Three female rabbits

Details on study design:

TEST SITE
- Area of exposure: an area of 10 x 10 cm was clipped and divided into four fiels. The two anterior fields were used for testing the substance.
- Type of wrap if used: to each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the test substance was applied, and the patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely woud around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with mild soap and luke warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Skin readings for erythema/easchar and oedema formation were made 1, 24, 48 and 72 hours as well as 7 days after termination of exposure.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the criteria listed in Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.

Executive summary:

The primary skin irritant effect of the test substance was investigated according to the method recommended in OECD guideline No. 404 "Acute Dermal Irritation/Corrosion", 1992 and EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.

Three female albino rabbits were exposed to the test substance at two skin site on the back. After 4 hours of exposure the test substance was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7 days after termination of exposure.

Slight to well-defined skin reactions were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for skin irritation. Effects were fully reversible at 7 days after termination of exposure, except some slight scale formation on the skin of one rabbit.

In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as a skin irritant.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD guideline No. 405 and under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted compete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): domestic quality drinking water, ad libitum
- Acclimation period: one week

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

IN-LIFE DATES: From: To: 4 January 1999 - 12 January 1999

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted test substance

Duration of treatment / exposure:

The left eye of the rabbit was treated. The right eye remained untreated and served as control. 0.1 ml of the test substance was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second.

Observation period (in vivo):

The eyes were examined and the grade of ocular reactions was recorded at 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

Three female rabbits.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the first 24 hour reading, fluorescin was instilled. After rinsing with 20 ml 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage.
- Time after start of exposure: 24 hours

SCORING SYSTEM: The eyes were examined at 1, 24, 48 and 72 hours after treatment for possible damage to the corena, iris and conjunctivae.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 48 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the criteria listed in Directive 93/21/EEC of 27 April, 1993. the test substance shall not be classified as an eye irritant.

Executive summary:

The eye irritant effect of the test substance (SAT 981 170) was investigated according to the method recommended in OECD guideline No. 405, "Acute Eye Irritation/Corrosion' and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)".

Three female albino rabbits were exposed to 0.1 ml of the test substance in the left eye. The eyes were examined and the changes were graded according to a numerical scale at 1, 24, 48 and 72 hours after dosing. Very slight signs of eye irritation were observed among the rabbits, but the mean scores at 24, 48 and 72 hours were below the EC criteria for eye irritation. Effects were fully reversible 72 hours after exposure.

In conclusion, according to Directive 93/21/EEC of April 27, 1993, the test substance shall not be classified as an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the available information. the test substance did not show skin and eye irritancy in two well-conducted in vivo studies. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for selection of skin irritation / corrosion endpoint:
There is only in vivo skin irriation study available. This study has been conducted according to OECD guideline no. 404 and under GLP.

Justification for selection of eye irritation endpoint:
There is only in vivo eye irriation study available. This study has been conducted according to OECD guideline no. 405 and under GLP.

Justification for classification or non-classification

The test substance did not show skin and eye irritancy in two well-conducted in vivo studies. Therefore, there is no need to classifiy the substance for skin- or eye irritancy, according to the Regulation 1271/2008 and the Directive 67/548/EEC.