Methyl undec-10-enoate

Endpoint summary

Description of key information

-Skin irritation : Test substance is not a skin irritant. An in vivo test, according to OECD guideline (404) in rabbits (CIT 1984) is available.
-Eye irritation : Test substance is not an eye irritant. An in vivo test, according to OECD guideline (405) in rabbits (CIT 1984) is available.

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:

1984-05-22 till 1984-07-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France (76410 Saint-Aubin-les-Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 2.4 ± 0.08 kg
- Housing: individual housing in poly styrene cages 0,32 x 0,35 x 0,55 m
- Diet (e.g. ad libitum): pelleted rabbit diet ad libitum
- Water (e.g. ad libitum): Millipore filtered water ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50% ± 20%
- Air changes (per hr): air filtered, non-recycled
- Photoperiod (hrs dark / hrs light): 12 h / 12 h


IN-LIFE DATES: From: 1984-05-15 To: 1984-05-25

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

3 days

Number of animals:

6 (males)

Details on study design:

TEST SITE
- Area of exposure: right flank (6 cm²)
- % coverage: 100 %
- Type of wrap if used: hydrophilic gauze bandage, kept in place by semiocculsive adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:


SCORING SYSTEM: Draize's score

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable, since no adverse skin reaction occurred

Irritant / corrosive response data:

No erythema and no oedema have been observed during the experiment.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Guidance to Regulation (EC) No 1272/2008 on CLP of substances and mixtures

Conclusions:

No erythema and no oedema have been observed during the experiment. Therefore the test item has to be classified as non irritating to skin.

Executive summary:

The subject of this study was to determine the skin irritation potential of test item methyl 10 -undecenoate by an in-vivo study with rabbits acc. to OECD guideline 404 (topical application). A volume of 0.5 ml of undiluted test item was tested upon abraded rabbit skin. Contact time was 4 h, observation time 72 h. Neither erythema nor oedema has been noticed. According to the experimental conditions used, methyl10-undecylenate can be considered and classified as non-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

Study period:

1984-05-15 till 1984-07-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study (OECD 405)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River France (Saint-Aubin-les-Elbeuf, Cléon, France)
- Age at study initiation: no data
- Weight at study initiation: 2.4 ± 0.08 kg
- Housing: individual housing in poly styrene cages 0,35 x 0,55 x 0,32 m
- Diet (e.g. ad libitum): pellted rabbit diet ad libitum
- Water (e.g. ad libitum): Millipore membrane filtered water ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): filtered air, non recycled
- Photoperiod (hrs dark / hrs light): 12 h / 12 h


IN-LIFE DATES: From: 1984-05-15 To: 1984-05-25

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not applicable


SCORING SYSTEM: Acc. to OECD guideline 405, the grading of ocular responses is necessarily subjective. Extensive documentation is needed to make thses subjective observations meaningful. A scoring system of 1 (slight effect) to 4 (most sever effects) was applied.


TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: No effects at 48 and 72 hours

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: No effects at 48 and 72 hours

Irritant / corrosive response data:

Significant conjunctival erythema has been observed in all animals, one hour after instillation. On day 1, a corneal diffuse opacification zone (smaller than 25% of the corneal surface) has been noticed in 4 rabbits. On day 2, these reactions had vanished. No reactions concerning the iris were observed.

Other effects:

none reported

Tab. 1: Scores of eye reactions observed

Scores	1 hour						Day 1
No. of rabbit	1	2	3	4	5	6	1	2	3	4	5	6
chemosis	0	0	0	0	0	0	0	0	0	0	0	0
conjunctival erythema	2	2	2	2	2	2	1	1	1	0	1	0
iris	0	0	0	0	0	0	0	0	0	0	0	0
cornea	0	0	0	0	0	0	1	1	0	1	0	1

Day 2 and day 3: All scores zero

Interpretation of results:

slightly irritating

Remarks:

Migrated information but not classified Criteria used for interpretation of results: other: Guidance to Regulation (EC) No 1272/2008 on CLP of substances and mixtures

Conclusions:

Under the experimental conditions used, methylundecylenate needs not to be classified as to its eye irritating potential.

Executive summary:

The potential of ocular irritation has been determined by instilling methyl-10-undecenoate in the conjunctival sac of New Zealand rabbits. The method acc. to OECD Guideline 405 was applied. The applied test item volume was 0.1 ml, the observation period was 72 h. Some significant conjunctival enanthema has been observed in all animals (6 of 6), one hour after instillation ("score 2", i.e. diffuse erythema, crimson colour, individual vessels not easliy discernable). On day 1, a corneal diffuse opacification zone (smaller than 25% of the corneal surface) has been noticed in 4 of 6 rabbits ("score 1"). On day 2, all these reactions had vanished. No iris irritation reaction has been observed. Under the experimental conditions used, methyl-10-undecenoate needs not to be classified as to its eye irritating potential.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation :

During the study on skin irritation with a test item application of 0.5 ml (undiluted) during 4 hours, no irritating effect was observed (overall irritation score = 0/4), 24, 48 and 72 hours after exposition.

Eye irritation :

The study on eye irritation with a dose application of 0.1 ml revealed the result "moderately irritating". No chemosis, iritis were observed. Redness of conjuntive and cornea opacity were observed at 24 hours in 4 rabbits, these effects were fully reversible at 48 hours.

Justification for classification or non-classification

Skin irritation :

According to EU regulation (EC) No. 1272/2008 (CLP) and to EU 67/548/ECC classification system, methyl undec-10 -enoate is not classified.

Eye irritation :

According to EU regulation (EC) No. 1272/2008 (CLP) and to EU 67/548/ECC classification system, methyl undec-10 -enoate is not classified.