Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from online Chemical Repository Database

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Acute Dermal Toxicity (LD50) Study in the Albino Rabbit assess for 14 days.
GLP compliance:
not specified
Test type:
other: Acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3-Phenoxybenzyl alcohol
- Molecular formula (if other than submission substance): C13H12O2
- Molecular weight (if other than submission substance): 200.23318 g/mol
- Smiles notation (if other than submission substance): C1=CC=C(C=C1) OC2=CC=CC (=C2) CO
- InChl (if other than submission substance): InChI=1S/C13H12O2/c14-10-11-5-4-8-13(9-11)15-12-6-2-1-3-7-12/h1-9, 14H, 10H2
- Substance type: Organic
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Age at study initiation: No data available
- Weight at study initiation: 2318 to 2925 grams
- Fasting period before study: No data available
- Housing: housed in hanging wire-mesh cages in temperature and humidity controlled quarters
- Diet (e.g. ad libitum): Purina Rabbit Chow(ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled quarters(°C not mention)
- Humidity (%): humidity controlled quarters (% not mention)
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
MAXIMUM DOSE VOLUME APPLIED: 20000 mg/kg.
Doses:
2500, 5000, 10000 and 20000 mg/kg.
No. of animals per sex per dose:
8 male and 8 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequency: They were observed at 24 hours and daily thereafter for a total of 14 days for pharmacotoxic signs and dermal irritation

Weighing: Body weights were measured initially and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, gross necropsy.

Statistics:
No data available

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
95% CL:
6 702 - 14 921
Sex:
male
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
95% CL:
5 000 - 20 000
Sex:
female
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
95% CL:
5 000 - 20 000
Other findings:
Pharmacotoxic signs were observed during the 14-day observation period as hypo activity, decrease limb tone, ataxia, dehydration, emaciation etc.

Any other information on results incl. tables

Mortality:

Dosage level(mg/kg)

                        Total Mortalities

Male

Female

Total

2500

0/2

0/2

0/4

5000

0/2

0/2

0/4

10000

1/2

1/2

2/4

20000

2/2

2/2

4/4

Clinical signs:

Days

Erythema

Edema

Atonia

Desquamation

None

Very slight

slight

moderate

None

Very slight

slight

None

Very slight

slight

None

Very slight

slight

1-3

 

 

2/4

2/4

2/4

 

2/4

4/4

 

 

4/4

 

 

4*

 

 

3/3

 

 

2/3

1/3

1/3

 

2/3

3/3

 

 

5

1/3

 

2/3

 

2/3

 

1/3

1/3

 

2/3

3/3

 

 

6**

1/2

 

1/2

 

2/2

 

 

1/2

 

1/2

1/2

 

1/2

7

1/2

1/2

 

 

2/2

 

 

 

1/2

1/2

 

 

2/2

8

2/2

 

 

 

2/2

 

 

1/2

 

1/2

 

 

2/2

9

2/2

 

 

 

2/2

 

 

1/2

 

1/2

 

1/2

1/2

10

2/2

 

 

 

2/2

 

 

1/2

1/2

 

 

1/2

1/2

11-14

2/2

 

 

 

2/2

 

 

2/2

 

 

 

 

2/2

*1 of 4 rabbits dead.

**2 of 4 rabbits dead.

 

Body weight:

The following body weights were obtained during the 14-day observation period:

Dosage level(mg/kg)

Individual

Rabbit no.

Sex

Control

Weight

7 day weights

14 day weights

10000

31683

Male

2642

2050

2427

 

31685

Male

2583

Died

Died

 

31710

Female

2731

2363

2612

 

31714

Female

2768

Died

Died

Gross pathology:

Rabbits which were scarified following 14 days of observations.

Number Exhibiting Sign/Number necropsied

Dosage Level (mg/kg)

 

2500

          5000

           10000

Male

Female

Male

Female

Male

Female

No gross lesions

2/2

1/2

2/2

1/2

1/1

1/1

Stomach, green fluid contents

 

1/2

 

 

 

 

Stomach mucosa, dark red foci

 

1/2

 

 

 

 

Spleen, pale coloration

 

 

 

1/2

 

 

Sub-lumbar region, two areas of necrotic fat

 

1/2

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 value for the New Zealand white rabbits by 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) was found to be 10000 mg/kg.
Executive summary:

Acute toxicity test (Dermal) inNew Zealand white rabbits by 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) was performed.

8 Male and 8 female animals were used for the study at 2500, 5000, 10000 and 20000 mg/kg.They were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters.The rabbits weighed from 2318 to 2925 grams at the beginning of the study.Body weights were measured initially and at 7 and 14 days.They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.L.H.) entitled "Guide for the Care and Use of Laboratory Animals.

The hair was removed from the back of each rabbit. The skin of one male and one female in each group was abraded with a scalpel blade.The test material was applied once only to the backs of the rabbits. The area wrapped with gauze bandaging and occluded with Saran Wrap and observed for 14 days. Gross necropsy was done if some rabbits were died during 14 days and at the end of 14 days.

 

From the above study and observations, the LD 50 value for the New Zealand white rabbits by 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) was found to be 10000 mg/kg.