Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Endpoint summary

Description of key information

Acute oral toxicity of  phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene was tested in two studies with (5 male and 5 female) rats, during 14 days. In addition, acute dermal toxicity of  phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene was tested in one study with (5 male and 5 female) rats, during 7 days.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 - 17 November, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed according to OECD Guideline 401 and EPA OPP 81-1 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not stated.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., UK
- Age at study initiation: 7 weeks
- Weight at study initiation: 150 - 202 kg
- Fasting period before study: yes, before dosing
- Housing: Stainless individual steel cages during study period
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26° C, minor deviations
- Humidity (%): 40 - 70%, minor deviations
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: unspecified

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/ml

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based upon dose-range-finding and consultation with sponsor

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4 hours, once daily through day 15, body weight on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Body weights are presented as mean plus std.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: Soft feces and/or poor grooming in some animals during day 1 - 3

Gross pathology:

Mottled kidneys in one male observed, no other visible lesions reported

Other findings:

none

none

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

A study in 5 male and 5 female rats revealed that acute oral LD50 for Wingstay L was > 5000 mg/kg bw. The study was performed according to the general guidelines for acute oral toxicity under GLP conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch 1 study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Value:

mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 December 1987 - 04 January 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed according OECD Guideline 402, under GLP conditions. No deviations reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc. UK
- Weight at study initiation: 174 - 238 g
- Housing: Stainless steel cages, 5 animals per sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22° C
- Humidity (%): 50- 85%
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 8 X 5 cm
- Type of wrap if used: elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit): 3 - 5 drops of water

Duration of exposure:

14 days

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 3, 6, 24, 48 hour; 3, 6, 7, 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

none

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: No significant clinical signs reported.

Gross pathology:

No significant lesions reported.

Other findings:

none

none

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

A study in 5 male and 5 female rats revealed that acute dermal LD50 for Lowinox 22CP46 was > 2000 mg/kg bw. The study was performed according to the general guidelines for acute dermal toxicity under GLP conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1 study

Additional information

The data of all three studies meet the requirements of the current guidelines, although one should notice that the identity and quality of the tested substance is not sufficiently controlled/documented in any of the three studies. Assuming that 100% pure testing substances are used, an oral LD50 in male and female rats > 5000 mg/kg bw and a dermal LD50 in male and female rats > 2000 mg/kg bw are demonstrated.

Justification for selection of acute toxicity – oral endpoint

Klimisch 1 study

Justification for selection of acute toxicity – dermal endpoint

Klimisch 1 study

Justification for classification or non-classification

According to the results of the acute oral and dermal toxicity studies, the substance does not need to be classified according to the CLP Regulation.