Ethyltriphenylfosfonium bromide

Skin irritation / corrosion

Administrative data

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:

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:

According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyltriphenylfosfonium bromide

EC Number:

216-223-3

EC Name:

Ethyltriphenylfosfonium bromide

Cas Number:

1530-32-1

Molecular formula:

C20H20P.Br

IUPAC Name:

bromo(ethyl)triphenylphosphorane

Test material form:

solid

Details on test material:

Identification : ETHYL TRI-PHENYL PHOSPHONIUM BROMIDE
Appearance : White to off-white crystalline powder
Batch number : ETPB1/B/14016
CAS No. : 1530-32-1
AI Content (purity) : 99.7%
Manufactured date : February, 2014
Expiry Date : January, 2015 (Retest date)
Storage conditions : Room temperature (20 - 30 °C)

Specific details on test material used for the study:

Identification : ETHYL TRI-PHENYL PHOSPHONIUM BROMIDE
Appearance : White to off-white crystalline powder
Batch number : ETPB1/B/14016
CAS No. : 1530-32-1
AI Content (purity) : 99.79%
Manufactured date : February, 2014
Expiry Date : January, 2015 (Retest date)
Storage conditions : Room temperature (20 - 30 °C)
Safety precautions: Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal : No test item remained unused after dosing. Hence no disposal was done

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Details on test animals
Source: Procured from LIVEON BIOLABS PVT. LTD
Age : 4 to 4.5 Months (Approximately)
Sex : Female
Number of Animals: Three
Health Status : Healthy young adults and nulliparous and non-pregnant rabbits were used for the study.
Body weight of animals : Minimum: 2.312 kg and Maximum: 2.480 kg (Prior to Treatment)
Acclimatisation : Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item.
Identification : During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage card was labelled with at least study no., study type, test system, sex, dose, animal number, experimental start and experiment completion date.
Diet : All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200004.
Water : Aqua guard filtered tap water was provided ad libitum.
Husbandry : 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.

Environmental Conditions:
Temperature : Minimum: 20.50 °C, Maximum: 22.50 °C
Relative humidity : Minimum: 51.50 %, Maximum: 66.30 %
Light-dark-rhythm : 12:12
Air Changes: More than 12 changes per hour

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

0.5 gm of test item (pulverized form) moistened with 0.5 ml of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr
- Control site: 0.5 ml distilled water was applied at control site.

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema and edema (skin irritation) were found at the end of 72 hour observation period after patch removal.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

Skin Reaction

 

In Treated area Dose:0.5 gm of test item (moistened with 0.5 ml 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		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	Left	0	0	0	0	0	0	0	0
2	Confirmatory	Right	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

 

 

 

 

 

 

Individual Animal BodyWeight

Sex:Female

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	2.480	2.566
2	2.354	2.418
3	2.312	2.370

 

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: 1 = Normal.

 

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In Animals No.1 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. Hence the confirmatory test was conducted on additional two animals (no. 2 and 3) to confirm the non irritant nature of the test item. After 4 hours of exposure, animal no. 2 and 3 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. 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. Hence, under the experimental test conditions, it was concluded the test chemical was Non-Irritating to the skin of Female New Zealand White Rabbits and "Not Classified as Skin Irritant” as per CLP Classification.

Executive summary:

An Acute Dermal Irritation/corrosion Study of the test chemical in Rabbits, was performed as per OECD guideline No. 404. Three healthy young adult female New Zealand White rabbits were used for conducting acute dermal irritation/corrosion 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 contra lateral sites, approximately 24 hours prior to treatment. A dose of 0.5 gm of test item moistened with 0.5 ml of distilled water was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one 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 cotton soaked in distilled 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, animal no. 1 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. Hence the confirmatory test was conducted on additional two animals (no. 2 and 3) to confirm the non-irritant nature of the test item. After 4 hours of exposure, animal no. 2 and 3 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. In Animals No.1 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. Hence the confirmatory test was conducted on additional two animals (no. 2 and 3) to confirm the non-irritant nature of the test item. After 4 hours of exposure, animal no. 2 and 3 revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. 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. Hence under the experimental test conditions, it was concluded the test chemical was Non-Irritating to the skin of Female New Zealand White Rabbits and "Not Classified as Skin Irritant” as per CLP Classification.