Petrolatum (petroleum), oxidized, Bu ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

3 December 2001 to 6 December 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, conducted to a valid guideline and was performed under GLP conditions. Since the study was conducted with the read across substance, hydrocarbon waxes (petroleum), oxidised, it has been assigned a reliability score of 2. Read across from this substance is justified on the basis of its similar physical and chemical properties to those of the registered substance. Furthermore, it has a very similar chemical structure; the registered substance is an esterified form of the read across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbon waxes (petroleum), oxidized

EC Number:

265-205-1

EC Name:

Hydrocarbon waxes (petroleum), oxidized

Cas Number:

64743-00-6

Molecular formula:

Not applicable to a UVCB substance

IUPAC Name:

Hydrocarbon waxes (petroleum), oxidized

Test material form:

other: greasy solid

Details on test material:

- Physical appearance: Light brown semi-solid
- Storage condition of test material: Room temperature and humidity
- TAN: 24 - 40

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Lads, Amherst, MA, USA
- Only healthy animals free from ocular damage were selected for this study
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 3.2 - 3.4 kg
- Housing: Individually in suspended cages
- Diet: Animals fed daily rations of Purina Rabbit Chow, diet # 5321, supplied by Purina Mills, Inc., USA
- Water: as libitum
- Quarantine period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/rabbit

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three female animals

Details on study design:

METHOD
- The test material was placed into the conjunctival sac, formed by gently pulling the lower eyelid away from the eye. The lid was held closed for a second, before the animal was released.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.

SCORING SYSTEM: Reactions were assessed according to the Draize scale (1977), which can be seen in table 1.

OBSERVATIONS
-Time points: 1, 24, 48 and 72 hours
- General health was recorded at each time point
- Body weights were recorded before exposure

TOOL USED TO ASSESS SCORE:
- A Mini-Maglite® was during ocular examinations
- Sodium fluorescein dye was used at 24 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

80

Remarks on result:

other: No reaction observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

10

Remarks on result:

other: No reaction observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.66

Max. score:

20

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72 hours.

Other effects:

No abnormal physical signs were noted during the observation period.

Any other information on results incl. tables

Table 2. Results for Ocular Damage

Animal No.	Tissue	Reading	1 hr	24 hrs	48 hrs	72 hrs	Mean Score from 24, 48 and 72 hours
1	Cornea	Opacity	0	0	0	0	0
		Area	0	0	0	0
	Sub-total		0	0	0	0
	Iris		0	0	0	0	0
	Sub-total		0	0	0	0
	Conjunctiva	Redness	2	0	0	0	0
		Chemosis	2	0	0	0	0
		Discharge	2	0	0	0
	Sub-total		12	0	0	0
	Total		12	0	0	0
2	Cornea	Opacity	0	0	0	0	0
		Area	0	0	0	0
	Sub-total		0	0	0	0
	Iris		0	0	0	0	0
	Sub-total		0	0	0	0
	Conjunctiva	Redness	2	1	0	0	0.33
		Chemosis	2	0	0	0	0
		Discharge	2	0	0	0
	Sub-total		12	2	0	0
	Total		12	2	0	0
3	Cornea	Opacity	0	0	0	0	0
		Area	0	0	0	0
	Sub-total		0	0	0	0
	Iris		0	0	0	0	0
	Sub-total		0	0	0	0
	Conjunctiva	Redness	2	1	1	0	0.66
		Chemosis	2	0	0	0	0
		Discharge	2	0	0	0
	Sub-total		12	2	2	0
	Total		12	2	2	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.

Executive summary:

In a GLP compliant study performed according to the standardised guideline EPA OPPTS 870.2440, the ocular irritation caused by exposure to the test material was assessed in three rabbits. 0.1 mL of the test material was administered into one eye of each of three rabbits, the other eye remained untreated and served as a control. Initially some mild irritation (chemosis and discharge) was observed, however this did not persist past 1 hour. Conjunctival redness was the parameter which persisted past the 1 hour observation time point. Conjunctival redness was assigned an average score of 0.33 according to the Draize scale (1977), this was completely reversible within 72 hours. Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant.