Formaldehyde, oligomeric reaction products with phenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data from authoritative database

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study in Rat for test chemical

Author:

U.S .National library of medicine

Year:

2017

Bibliographic source:

ChemID plus A TOXNET DATABASE.2017

Reference 2

Reference Type:

secondary source

Title:

Acute biological studies on range oftest chemical

Author:

NTRL

Year:

1992

Bibliographic source:

National Technical Information Service

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of test chemical was performed in rats

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Formaldehyde, oligomeric reaction products with phenol

EC Number:

500-005-2

EC Name:

Formaldehyde, oligomeric reaction products with phenol

Cas Number:

9003-35-4

Molecular formula:

(C6H6O.CH2O)x

IUPAC Name:

Formaldehyde, oligomeric reaction products with phenol

Details on test material:

- Name of test material (as cited in study report): Phenol-formaldehyde resin
- Molecular formula: C6H6O.CH2O)x-
- Molecular weight: 34.133 g/mol
- Substance type: organic
- Physical state: solid
- Smiles notation: c1(c(c(ccc1)[CH])O)O[CH]
- InChl: 1S/C8H6O2/c1-6-4-3-5-7(10-2)8(6)9/h1-5,9H

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available

Doses:

As mentioned in table below

No. of animals per sex per dose:

Total :10
male:5
female:5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: No data available
- Other examinations performed: clinical signs and postmortem examination
Were performed

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed

Clinical signs:

other: No data available

Gross pathology:

No data available

Other findings:

Acute oral studies indicate that LD50 values of test chemical in the rat are proportional to their free test substance content.

Any other information on results incl. tables

SR.NO	Resin type	Clinical signs
1	Phenol Formaldehyde Novolak Ground With Hexamine (6%)	Tremors and convulsion in animal subsequent prostration with twitching and staining around the mouth & chin.
2	Phenol Formaldehyde Novolak Ground With Hexamine (9.1%)	Nothing abnormal detected.
3	Ground Phenol Formaldehyde Novolak Without Hexamine	Nothing abnormal detected.
4	Cashew Modified Phenol Formaldehyde Novolak Ground With Hexamine (7. 9%)	Slight Tremors in 4 animals. Salivation and resultant fur staining with evidence of gastro-intestinal disturbance.
5	Spray Dried Phenol Formaldehyde Resol	Seadation, Ruffled fur and arched posture.
6	Resorcinol Phenol Formaldehyde Novolak In Ethanol (7. 5%)	Seadation and convulsion with Ruffled fur and arched posture.
7	Phenol Formaldehyde Resol In Ethanol (43%)	Nothing abnormal detected.
8	Phenol Formaldehyde Resol In Ethanol    (19. 7%)	Seadation and convulsion with Ruffled fur and arched posture.
9	Phenol Formaldehyde Resol In Ethanol (30%)	Transient salivation and transient staining.
10	Water Dilutable Phenol Formaldehyde Liquid Resol	Transient salivation (with associated staining) and body Tremors at all dose level. Some staining in urogenital region.
11	Phenol Formaldehyde Liquid Resol	Seadation, Ruffled fur, arched posture. Some convulsion at highest dose level
12	Phenol Formaldehyde Liquid Resol	Transient salivation and associated staining slight body tumor in one animal.
13	Phenol Formaldehyde Liquid Resol	Tumors and convulsion with prostration and twitching at both dose level. Salivation was seen in almost all animals. No treatment related microscopic change at autopsy in all surviving animals

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 value was considered to be >5000 mg/kg,when male and female rats were treated with test chemical orally.

Executive summary:

Acute oral toxicity test was carried out for different grades of test chemical. Groups of five male and five female rats were given single oral doses of the test materials. The animals were observed at frequent intervals for the first day and then at least daily over a 14-day observation period. All the animals dying during this period and the surviving animals, which were killed on day 14, were subjected to a post mortem examination to note any microscopic abnormalities.Administration of different grades of test chemical in male and female rat resulted in no or minimum, sign of toxicity at doses up to 5000 mg/kg. Hence,The LD50 value was considered to be >5000 mg/kg,when male and female rats were treated with test chemical orally.