Benzoic acid, 4-[(1-oxodecyl)oxy]-

Endpoint summary

Description of key information

Skin irritation / corrosion:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. 
Thus, the test item did not induce significant or irreversible damage to the skin.
Eye irritation:
The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.33 and 1.00 for reddening, respectively, and 0.00 for chemosis for each of the three animals.  These effects were fully reversible and were no longer evident 7 days after treatment. A slight reversible corneal opacity was noted in one animal at the 1-hour reading. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 13 weeks (male), 10 weeks (females)
- Weight at study initiation: 2506, 2062, 2019 grams
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g moistened with approximately 0.5 mL of purified water

Duration of treatment / exposure:

The duration of treatment was 4 hours

Observation period:

The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 4 cm x 4 cm
- Type of wrap if used: gauze patch / semi-occlusive dressing / wrapped with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours (flushed with lukewarm tap water)

SCORING SYSTEM: scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004

Irritation parameter:

erythema score

Basis:

animal: # 1,2,3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (erythema) at any time

Irritation parameter:

edema score

Basis:

animal: # 1,2,3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Irritant / corrosive response data:

not staining, not corrosive, no skin reactions

Other effects:

no clinical signs

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria, the test item is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. 0.5 g of the test item moistened with purified water was applied by topical semi-occlusive application of to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 13 weeks (male), 10 weeks (females)
- Weight at study initiation: 2594, 2158, 2158 grams
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as the reference control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (per animal)
- Concentration (if solution): undiluted

VEHICLE
- no vehicle used

Duration of treatment / exposure:

single application (conjunctival sac of the left eye) without rinsing

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48, 72 hours , as well as 7 days after administration.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were not rinsed

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland)

Irritation parameter:

cornea opacity score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: initial slight signs of irritation were fully reversible within 24h

Irritation parameter:

iris score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no signs of irritation (iris) at any time

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: # 1, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: mean of 24, 48, 72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (chemosis) at any time

Irritant / corrosive response data:

The instillation resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment. A slight reversible corneal opacity was noted in one animal at the 1-hour reading. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed.

Other effects:

No clinical signs were observed

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria, the test item is considered to be "not irritating" to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.33 and 1.00 for reddening, respectively, and 0.00 for chemosis for each of the three animals. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. A slight reversible corneal opacity was noted in one animal at the 1-hour reading. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage 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:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

Mean scores determined for skin corrosion/irritation and serious eye damage/eye irritation are below the defined threshold values. Since these findings do not meet the criteria for classification according to the rules laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.