Formaldehyde, oligomeric reaction products with phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from saftey asessment report

Data source

Reference

Reference Type:

secondary source

Title:

INITIAL SUBMISSION: TOXICOLOGICAL INVESTIGATION OF CP 40000 WITH COVER LETTER DATED O8OS92

Author:

NTRL report

Year:

1992

Bibliographic source:

NTRL REPORT - OTS0546159; August 5, 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

An eye irritation test was carried out in albino rabbits for test chemical to assess its irritation potential.

GLP compliance:

not specified

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

Test material form:

solid

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 / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Amount: 100 mL
concentration applied: 100%

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 (Male/female)

Details on study design:

TEST SITE
- Area of exposure: conjunctival sac of right eye
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with warm isotonic saline solution after 24 hours reading.


-SCORING SYSTEM: The data scored according to the method of Draize et, al.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

10.6

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Slightly irritating effects were observed.

Any other information on results incl. tables

Animal no	Sex	1 hour	24 hour	48 hour	72 hour	120 hour	168 hour
1	Male	8	12	2	0	0	0
2	Female	6	10	0	0	0	0
3	Male	8	10	2	0	0	0
Average		7.3	10.3	1.6	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The treated animals produced slight ocular reactions with the average score was 10.6 out of maximum score of 110. Hencechemical was considered to be Slightly irritating to the albino rabbits

Executive summary:

An eye irritation test was carried out in 3 albino rabbits for test chemical to assess its irritation potential.

 

100ml undiluted test chemical was installed into theconjunctival sac of right eye of each rabbit.The left eye served as control.The eyes were rinsed with warm isotonic saline solution after 24 hours reading and reactions were scored up to 7 daysaccording to the method of Draize for inflammation.

 

The treated animals produced slight ocular reactions with the average score was 10.6 out of maximum score of 110. Hencechemical was considered to be Slightly irritating to the albino rabbits