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

Acute Toxicity: dermal

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

271-867-2

EC Name:

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

Cas Number:

68610-51-5

Molecular formula:

C10H12.C7H8O.C4H8

IUPAC Name:

2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol

Details on test material:

- Name of test material (as cited in study report): Lowinox 22CP46
(Lowinox 22CP46 is a precursor of Lowinox CPL; Lowinox 22CP46 mainly consists of lower MW components of the current Lowinox CPL, which has a wider MW range (information provided by sponsor))
- Substance type: off-white powder
- Physical state: solid
- Analytical purity: not mentioned
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: 4671
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: not mentioned

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Any other information on results incl. tables

none

Applicant's summary and conclusion

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.