1-phenoxypropan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guidelines with acceptable restrictions (non-GLP, unknown purity of the testing substance)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Reference 2

Reference Type:

secondary source

Title:

SIDS for Propylene Glycol Phenyl Ether - CAS No: 770-35-4 (major isomer - Secondary Alcohol), 4169-04-4 (minor isomer - Primary Alcohol), 41593-38-8 (commercial mixed isomer product)

Author:

OECD

Year:

2006

Bibliographic source:

SIDS Initial Assessment Report For - SIAM 18- Paris, France, 20-23 April 2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-phenoxypropan-2-ol

EC Number:

212-222-7

EC Name:

1-phenoxypropan-2-ol

Cas Number:

770-35-4

Molecular formula:

C9H12O2

IUPAC Name:

1-phenoxypropan-2-ol

Constituent 2

Reference substance name:

1-phenylpropan-2-ol

EC Number:

211-821-0

EC Name:

1-phenylpropan-2-ol

Cas Number:

698-87-3

IUPAC Name:

1-phenylpropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Solvenon PP (Propylene glycol phenyl ether)
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rat/Wistar/Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 180 - 210 g
- Fasting period before study: withdrawal of food about 16 hours before sacrifice
- Housing: 5 animals per stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 or 20 g in 100 ml

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg

Doses:

1000 and 2000 mg/kg body weight

No. of animals per sex per dose:

5/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After dosing, signs and symptoms were monitored several times on the first day and at least daily thereafter on workdays. Animals were checked for morbidity and mortality twice per day on workdays and once per day on holidays. Body weights were noted on a weekly basis
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology
Young adult male and female Wistar rats (5/sex/group) were administered single gavage doses of 1000 or 2000 mg/kg Solvenon PP (propylene glycol phenyl ether, PPh) in an olive oil vehicle.   Rats were observed for mortality and signs of toxicity for 14 days after  administration of the test material.   Rats were administered a single gavage dose of the test compound during the morning of day 1 after being fasted for 16 hours over the previous night. After dosing, signs and symptoms were monitored several times on the first day and at least daily thereafter on workdays. Animals were checked for morbidity and mortality twice per day on workdays and once per day on holidays.  Rats were fasted for 16 hours prior to final euthanization with CO2 on day 14 and were subjected to gross necropsy.

Statistics:

not performed

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One male rat from the high dose group (2000 mg/kg group) died on day 1; all remaining rats survived the 14-day observation period.

Clinical signs:

other: Rats from both dose groups exhibited dyspnea, apathy, and poor general state. In the high dose group, additional symptoms included apathy, abnormal stance, staggering, atonia, paresis, absence of pain reflex, absence of corneal reflex, piloerection, and d

Gross pathology:

No grossly observable lesions were reported in the remaining subjects that survived until study termination.

Other findings:

not applicable

Any other information on results incl. tables

Table 1: Results

Group	PPh dose (mg/kg)	PPh/Olive oil ratio (mg/ml)	Volume	No. exposed	No. dead (male)	No. dead (female)	Total dead
1	1000	200 mg/ml	5 ml	5	0/5	0/5	0/10
2	2000	100 mg/ml	5 ml	5	1/5	0/5	1/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for Solvenon PP (propylene glycol phenyl ether, PPh) was greater than 2000 mg/kg in rats. Based on the results of the study, Solvenon PP was not classified according to EU classification

Executive summary:

In this study, young adult male and female Wistar rats (5/sex/group) were administered single gavage doses of 1000 or 2000 mg/kg Solvenon PP (propylene glycol phenyl ether, PPh) in an olive oil vehicle.   Rats were observed for mortality and signs of toxicity for 14 days after  administration of the test material.   Rats were administered a single gavage dose of the test compound during the morning of day 1 after being fasted for 16 hours over the previous night. After dosing, signs and symptoms were monitored several times on the first day and at least daily thereafter on workdays. Animals were checked for morbidity and mortality twice per day on workdays and once per day on holidays.  Rats were fasted for 16 hours prior to final euthanization with CO2 on day 14 and were subjected to gross necropsy.

One male rat from the high dose group (2000 mg/kg group) died on day 1; all remaining rats survived the 14-day observation period. Rats from both dose groups exhibited dyspnea, apathy, and poor general state. In the high dose group, additional symptoms included apathy, abnormal stance, staggering, atonia, paresis, absence of pain reflex, absence of corneal reflex, piloerection, and dehydration. Generally, these signs disappeared after the first day. Rats from both dose groups exhibited dyspnea, apathy, and poor general state. In the high dose group, additional symptoms included apathy, abnormal stance, staggering, atonia, paresis, absence of pain reflex, absence of corneal reflex, piloerection, and dehydration. Generally, these signs disappeared after the first day. No grossly observable lesions were reported in the remaining subjects that survived until study termination.

The oral LD50 for Solvenon PP (propylene glycol phenyl ether, PPh) was greater than 2000 mg/kg in rats. Based on the results of the study, Solvenon PP was not classified according to EU classification