Formaldehyde, oligomeric reaction products with phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 dermal 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

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

No data available

Duration of exposure:

24hr

Doses:

As mentioned in table below

No. of animals per sex per dose:

Total :10
male:5
female:5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: clinical signs, body weight, histopathology were observed

other: To prevent the animals from gaining access to the sites of application (and hence
Probably ingesting the test material) acetate collars were placed around each rat's neck for a further 24 hours.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was not observed at given dose

Mortality:

Mortality observed only for test chemical In IHS (7. 5%).
At 2000 mg/kg- 3/10
At 2500 mg/kg - 9/10
At 3000 mg/kg - 9/10
At 4000 mg/kg - 10/10

Clinical signs:

other: As mentioned in table below

Gross pathology:

No data available

Other findings:

No data available

Any other information on results incl. tables

SR.NO	Resin type	Clinical signs
1	Unground Phenol Formaldehyde resol	Slight sedation and ruffled fur. Mild redness swelling on test site.
2	Resorcinol Phenol Formaldehyde Novolak In IHS (7. 5%)	Sedation and ruffled fur. mild redness swelling on test site
3	Phenol Formaldehyde Resol In Ethanol (43%)	Nothing abnormal detected
4	Phenol Formaldehyde Resol In IHS  (19. 7%)	Slight sedation and ruffled fur. and curved posture
5	Phenol Formaldehyde liquid Resol	Sedation and ruffled fur. mild redness swelling on test site
6	Phenol Formaldehyde liquid Resol	Nothing abnormal detected. Skin stained at test site
7	Water Dilutable Phenol Formaldehyde Liquid Resol	Nothing abnormal detected. Well depend redness on test site on female animals for 24 hrs following patches removal.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 value was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application

Executive summary:

Acute dermal toxicity test was carried out for different grades of test chemical. Groups of five male and five female rats were exposed to single doses of selected resin applied to the skin under occlusion for 24 hours.A similar group, exposed to the patches alone, served as controls.The animals were observed for 14 days following exposure for signs of toxicity.No fatalities occurred, except at the higher treatment levels with test chemical in ethanol containing 23% free phenol, during the observation period although evidence of irritancy was noted with certain grades. Bodyweight gain was essentially similar in treated and control animals and no significant macroscopic changes were seen in the organs at autopsy.Dermal LD values for all the grades examined under the conditions of exposure, considered to exceed 2000 mg/kg. Hence, The LD50 value was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application.