Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

EC Number:

700-960-7

Cas Number:

68512-30-1

Molecular formula:

not applicable

IUPAC Name:

Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

Test material form:

liquid: viscous

Details on test material:

- Manufacturers identification: Novares LA 300
- Substance type: organic
- Test material is 'Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol' (OAPP), EC list number 700-960-7 (assigned manually to validated substances from inquiries by ECHA). Originally the substance phenol, methylstyrenated, CAS No. 68512-30-1, EC No. 270-966-8 was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA.
- for additional information see respective study record

Specific details on test material used for the study:

- Name of test material (as cited in study report): Necires EPX-L (phenol, methylstyrenated)
- Impurities (identity and concentrations): None
- Purity test date: Unknown
- Lot/batch No.: 9356059
- Expiration date of the lot/batch: 2005/02/01
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2683 -2763 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITl, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week. Certificates of analysis were examined and retained in the NOTOX archives.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100 %

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: OECD 405, Draize et a1. 1944. J. Pharmacal. Exp. Ther. 82; 377-390 and J. Soc. Cosmet. Chem. 13; 281-289

TOOL USED TO ASSESS SCORE: fluorescein

CONTROL
The eye not being treated served as a control

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 13

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Instillation of 0.1 ml of NECIRES EPX-L into one eye of each of the animals resulted in minimal irritation of the conjunctivae. The irritation consisted of chemosis in two animals (nos. 1941 and 1975) and redness in all three animals, which had completely resolved within 48 hours after instillation. A small amount of discharge was also observed in one animal (no. 1941) 1 hour after instillation. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.

Other effects:

There was no evidence of ocular corrosion nor was there any peri-ocular staining of tissues by the test substance.
No toxic symptoms were observed in the animals during the test period and nomortality occurred.

Any other information on results incl. tables

INDIVIDUAL OCULAR CHANGES

Time after dosing	Tissue/Finding	Animal 1935 (#1)	Animal 1941 (#2)	Animal 1975 (#3)
1 hour	Corneal opacity              area	0 0	0 0	0 0
	Iris	0	0	0
	Conj.: redness           chemosis	1(A,B,C) 0	1(A,B,C) 1(A)	1(A,B,C) 1(A)
	Discharge	0	1	0
24 hours	Corneal opacity              area	0 0	0 0	0 0
	Iris	0	0	0
	Conj.: redness           chemosis	0 0	1(A,C) 0	0 0
	Discharge	0	0	0
48 hours	Corneal opacity              area	0 0	0 0	0 0
	Iris	0	0	0
	Conj.: redness           chemosis	0 0	0 0	0 0
	Discharge	0	0	0
72 hours	Corneal opacity              area	0 0	0 0	0 0
	Iris	0	0	0
	Conj.: redness           chemosis	0 0	0 0	0 0
	Discharge	0	0	0

 

(.) = Score given for: A = Eyelids

                                B = Nictitating membrane

                                C = Sclera      

DRAIZE SCORE CALCULATIONS

Animal no.	Tissue	Hours after application
		1 hour	24 hours	48 hours	72 hours
1935 (#1)	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae	2	0	0	0
	Subtotal	2	0	0	0
1941 (#2)	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae	6	2	0	0
	Subtotal	6	2	0	0
1975 (#3)	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae	4	0	0	0
	Subtotal	4	0	0	0
	Total	12	2	0	0
	Mean total	4	0.7	0	0

                                   

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Necires EPX-L (phenol, methylstyrenated) is not irritating to eyes acccording to EU/GHS classification criteria as demonstrated in a test according to OECD TG 405.

Executive summary:

Three male rabbits had 0.1 ml phenol, methylstyrenated instilled in their eyes for 24 hours. Following this period, the test substance was washed out, using 2 % fluorescein in water to reveal any signs of irritation. The instillation resulted in minimal irritation of the conjunctivae, irritation of chemosis in two animals and redness in all three animals. In one animal a small amount of dicharge was observed 1 hour after instillation. These symptoms were resolved 48 hours after instillation, and no corneal epithelial damage was seen in any of the animals 24 hours after the instillation. There was no evidence of ocular corrosion nor was there any peri-ocular staining of tissues by the test substance. No toxic symptoms were observed in the animals during the test period, and no mortality occurred. In conclusion, instillation of the test substance into rabbit eyes induced minimal irritation, which was reversible within 48 hours.