Sodium phenylacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to assess the irritant and/or corrosive effects of “Benzyl propionate (CAS No. - 122-63-4)” after dermal application on the intact skin in Rabbits.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl propionate

EC Number:

204-559-3

EC Name:

Benzyl propionate

Cas Number:

122-63-4

Molecular formula:

C10H12O2

IUPAC Name:

benzyl propionate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report):Benzyl propionate
- Molecular formula :C10H12O2
- Molecular weight :164.20 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
- A.I Content:99.39 %
- Lot/batch No.:Lot 1/04
- Storage condition of test material:Tightly closed, in well-ventilated place. Keep away from source of ignition - no smoking.
- Other:
Handling and Disposal
Safety precautions : Take precautionary measures against static discharges. Keep away from source of ignition. When using do not eat or drink, Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the Personnel.
Disposal : The remaining unused test item (if any) was disposed as per internal SOPs of sa-FORD.

Specific details on test material used for the study:

Name of test material (as cited in study report):Benzyl propionate
- Molecular formula :C10H12O2
- Molecular weight :164.20 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
- A.I Content:99.39 %
- Lot/batch No.:Lot 1/04
- Storage condition of test material:Tightly closed, in well-ventilated place. Keep away from source of ignition - no smoking.
- Other:
Handling and Disposal
Safety precautions : Take precautionary measures against static discharges. Keep away from source of ignition. When using do not eat or drink, Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the Personnel.
Disposal : The remaining unused test item (if any) was disposed as per internal SOPs of sa-FORD.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Procured from RABBI ROOF, Hyderabad.
- Age at study initiation:4 to 5 Months (Approximately).
- Weight (Prior to Treatment):Minimum: 1.914 kg and Maximum: 2.358 kg
- Health Status :Healthy young adults and nulliparous and non-pregnant Rabbits were used for the study.
- Housing:The animals were housed individually in stainless steel cages.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed minimum twice a week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum.
- Acclimation period:Rabbits were acclimatised to the test conditions for a period of 5 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C and Maximum: 22.50 °C
- Humidity (%):Minimum: 43.80 % and Maximum: 68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

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

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure:The dorsal lumbar region at contralateral sites.
- % coverage:Approximately 6 X 6 cm.
- Type of wrap if used:A porous gauze dressing and non-irritating tape (Micropore 3”).

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using cotton soaked in distilled water.
- Time after start of exposure:4 hour

SCORING SYSTEM:Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 ,#2 and #3

Time point:

other: At 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 ,#2 and #3

Time point:

other: At 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritant / corrosive response data:

The following were observed in treated rabbits.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.

In Animals No.1, 2 and 3 after post patch removal, revealed no erythema and oedema at 24 and 48 and 72 hour during the observation period.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Other effects:

Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.

Mortality
No mortality was observed during the observation period.

Any other information on results incl. tables

Table 1

Skin Reaction

 

In Treated area Dose:0.5 ml of test item                                                               Sex:Female

 

Animal No.	Test	Treated area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Left	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

 

 

In Control area                 Dose:0.5 ml of distilled water                              Sex:Female

 

Animal No.	Test	Treated area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Right	0	0	0	0	0	0	0	0
2	Confirmatory	Left	0	0	0	0	0	0	0	0
3		Left	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                                                       Oedema

0 =No erythema                                                                                           0 =No oedema

Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours

 

Animal Number                   Observations	1	2	3
Erythema	0.00	0.00	0.00
Oedema	0.00	0.00	0.00

 

 

Table 2

Individual Animal BodyWeight

Sex:Female

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	1.914	2.032
2	2.350	2.370
3	2.358	2.364

 

Table 3

Individual AnimalClinicalSigns

Sex:Female

Animal No.	Days (Post dosing Observation)
	0	1	2	3
1	1	1	1	1
2	1	1	1	1
3	1	1	1	1

Key: ./. = Not Applicable. 1 = Normal.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

No erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, it was concluded that “Benzyl propionate (CAS No. - 122-63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and being classified as “Category- Not Classified” as per CLP Regulation.

Executive summary:

Acute Dermal Irritation/corrosion Study of “Benzyl propionate(CAS No. -122-63-4)”in Rabbits, was performed in a OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access). This study was performed as per OECD guideline No. 404.

 

Three healthy young adult female rabbits were used for conducting acute dermal irritation study.Body weights were re­corded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment.A dose of0.5 ml of test item (as such) wasappliedto the skin,over an area of approximately 6 x 6 cm clippedof haironone side of rabbits.The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.After 4 hours of exposure in Animal No. 1, there was no erythema and oedema observed at 1, 24, 48 and 72 hours observation.Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3)to confirm the non irritant nature of the test item. In Animals No. 2 and 3 after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. The patch was removed after 4 hours and rabbits wereobservedfor erythema and oedemaat 1, 24, 48 and 72 hours after patch removal, evaluatedand graded as per Draize method. The individual mean score at 24, 48 and 72 hoursfor Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.  

 

Hence, it was concluded that “Benzyl propionate (CAS No. - 122 -63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Regulation.