Octanoic acid, ester with 1,2,3-propanetriol

Endpoint summary

Description of key information

The skin and eye irritation of the test material, octanoic acid, ester with 1,2,3 -propanetriol, to the rabbit was found to be a mild skin irriatation and moderate irritation to the eye.

All available irritation studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral or dermal exposure route.
Studies on acute oral toxicity were available for the following members of this category (CAS No.):
26402-26-6, 73398-61-5 and medium and long chain triglycerols (MLCT).

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:

March 18th - March 25th, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Purity of test substance not given.

GLP compliance:

yes

Specific details on test material used for the study:

Imwitor 908

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.54 - 3.40 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 19
- Humidity (%): 45 - 48
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, surgical adhesive tap, elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
After exposure period of 4 h any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7d

Remarks on result:

probability of mild irritation

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

probability of weak irritation

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

probability of mild irritation

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

1.66

Max. score:

2

Reversibility:

fully reversible within: 7d

Remarks on result:

probability of mild irritation

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

probability of mild irritation

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

mean of

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

probability of mild irritation

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 tested animals and mean of

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Executive summary:

The test material, octanoic acid, ester with 1,2,3 -propanetriol, was found to be a mild irritant to rabbit skin.

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:

April 6th - April 11th, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

yes

Remarks:

purity of test substance not given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

purity of test substance not given

GLP compliance:

yes

Specific details on test material used for the study:

Imwitor 908

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.70 - 3.29 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 167- 20
- Humidity (%): 52 - 58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single eye instillation

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
No

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
standard ophthalmoscope

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 tested animals and mean of

Time point:

other: 24, 48 and 72 h

Score:

4

Max. score:

30

Reversibility:

fully reversible within: 7d

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 tested animals and mean of

Time point:

other: 24, 48 and 72 h

Score:

0.6

Max. score:

5

Reversibility:

fully reversible within: 7d

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 tested animals and mean of

Time point:

other: 24, 48 and 72 h

Score:

1.9

Max. score:

10

Reversibility:

fully reversible within: 7d

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified

Executive summary:

The test material, octanoic acid, ester with 1,2,3-propanetriol, was found to be a moderate irritant to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Study performed according to internationally accepted testing guideline, well documented.

Justification for selection of eye irritation endpoint:
Study performed according to internationally accepted testing guideline, well documented.

Effects on skin irritation/corrosion: mild irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

The available data on irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.