Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
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:
To observed acute inhalation toxicity given Inhalation exposure of rats for 1 hour to an aerosol and vapor atmosphere of 3 Phenoxybenzyl Alcohol at a concentration of 2.0 mg/l.
GLP compliance:
not specified
Test type:
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:
rat
Strain:
other: Charles River CD rats
Sex:
male/female
Details on test animals and environmental conditions:
- Source: the Ethyl Corporation, Ferndale,Michigan
- Age at study initiation: No data available
- Weight at study initiation:
Male rats :200 to 254 grams
Females rats: 200 to 220 grams
- Fasting period before study: No data available
- Housing: The rats were housed individually in wire-mesh cages and were kept throughout the pre- and post exposure periods in a temperature and humidity controlled room in accordance with standards outlined in the "Guide For the Care and Use of Laboratory Animals; DREW No. (N.LH. 74-23) 1974".

- Diet (e.g. ad libitum): Purina Laboratory Chow(ad libitum)
- Water (e.g. ad libitum): Water ( ad libitum)
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no temperature mention , only temperature control room given
- Humidity (%):no humidity mention , only humidity control room given
- Air changes (per hr):Not data available
- Photoperiod (hrs dark / hrs light): Not data available

IN-LIFE DATES: From: To: Not data available

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
No data available
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
2 mg/l
No. of animals per sex per dose:
5 male/ 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 48 hours

- Frequency of observations and weighing:
Frequency of observations: immediately following the 1 hour exposure period and twice daily after for 48 hours.

Frequency of weighing: Individual body weights were recorded prior to the 1 hour exposure and at 24 and 48 hours in order to detect any latent effects following the exposure.

- Necropsy of survivors performed: No necropsy was conducted because all of the rats survived the exposure and observation period.

- Other examinations performed: clinical signs, body weight

- other: The vapors and aerosols of the compound were generated by metering the liquid at the rate of 0.0494 ml/min with a Harvard® Infusion Pump into a positive pressure atomizer located near the chamber air inlet at the top of the exposure chamber. The "metered" concentration of the compound (2.0 mg/I) in the chamber atmosphere was calculated from the ratio of the rate of liquid dissemination (55.3 mg/min*) to the rate of total chamber airflow (27 l/min). The total chamber airflow represents the volume of air ejected from the atomizer plus the volume of make-up air.
Statistics:
No data available

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 2 other: mg/l
Based on:
test mat.
Exp. duration:
1 h
Mortality:
None of the rats died in the experiment
Clinical signs:
other: The immediate response of the rats to the experimental atmosphere was an increase of activity in preening. After several minutes of exposure, this activity decreased. The rats appeared normal during the experimental period.
Body weight:
Details given in table below
Gross pathology:
No necropsy was conducted because all of the rats survived the exposure and observation period and were sacrificed and discarded.

Any other information on results incl. tables

Body weight gain appeared normal during the 48 hour observation period

   

Individual Body Weights, Grams

Group,

Rat No.

Sex

Pre-exposure

Post-exposure (Days)

2.0 mg/l

 

 

 

16770

M

205

214

228

16771

M

254

260

270

16772

M

200

208

222

16773

M

203

211

212

16774

M

225

244

252

16775

F

220

226

232

16776

F

210

212

212

16777

F

208

215

220

16778

F

200

208

214

16779

F

218

232

233

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC0 value for the Charles River CD rat for 3-Phenoxybenzylalcohol (CAS No :13826-35-2) was found to be > 2 mg/l.
Executive summary:

Acute inhalation study was performed on Charles River CD rats at 2 mg/l concentration. 5 male of weight from 200 to 254 grams and 5 female from 200 to 220 grams were used. The rats were housed individually in wire-mesh cages and were kept throughout the pre- and post-exposure periods in a temperature and humidity controlled room in accordance with standards outlined in the "Guide For the Care and Use of Laboratory Animals; DREW No. (N.LH. 74-23) 1974".

During exposure, the rats were caged individually in compartmented,Wire-mesh exposure cages. The cages were placed in a 160- liter cubical. Stainless steel and glass chamber. Constant chamber airflow was maintained by means of a rotary centrifugal air pump located at the exhaust side of the chamber. The chamber exhaust was filtered with an activated charcoal filter and a Cambridge Absolute filter before being discharged outside of the laboratory.

 

Observations for pharmacotoxic signs and mortality were made during and immediately following the 1 hour exposure period and twice daily thereafter for 48 hours.

None of the rats died in the experiment. No necropsy was conducted because all of the rats survived the exposure and observation period and were sacrificed and discarded.

Therefore, the LC0 value of 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) for Charles River CD rat was found to be >than 2 mg/l.