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Toxicological information

Skin irritation / corrosion

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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 report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
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 test chemical after dermal application on the intact skin of rabbits.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Identification : STYRENATED PHENOL
Appearance : Clear yellowish viscous liquid
Batch number: Lot 2/04
CAS No.: 61788-44-1
AI Content : Monostyryl Phenol – 11.20%
Distyryl Phenol– 44.65%
Tristyryl Phenol– 43.59%
Manufactured date: May, 2013
Expiry Date : September, 2014
Storage conditions: Room temperature (20 - 30 °C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Species :Rabbits (Oryctolagus cuniculus)
Strain :New Zealand White
Age :4 to 4.5 Months (Approximately)
Sex :Female
Number of Animals:Three
Supplier/Source:Procured from LIVEON BIOLABS PVT. LTD. (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
Health Status :Healthy young adults rabbits were used for the study. Females were nulliparous and non pregnant.
Body weight of animals: Minimum: 2.168 kg and Maximum: 2.404 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 cards were labelled with at least project No., species, strain, group, sex, animal number, experiment start and end date.

Husbandry Conditions
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.

Experimental Room Condition
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:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): No data available

VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 ml distilled water
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available- Purity: No data available
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: 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method. 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.

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

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

 

 

 

 

 

In Control areaDose: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

Right

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

2.292

2.340

2

2.404

2.464

3

2.168

2.248

Table 3

Individual AnimalClinical Signs

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:
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, the test chemical was regarded as non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and is thus not classified as a skin irritant.
Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical was performed as per OECD guideline No. 404 using three healthy young adult female.

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 of 0.5 ml of test item (as such) 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 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.

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

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, it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified as Skin Irritant” as per CLP Classification.