Solvent naphtha (petroleum), heavy arom.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction

EC Number:

270-729-9

EC Name:

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction

Cas Number:

68477-40-7

IUPAC Name:

68477-40-7

Constituent 2

Reference substance name:

Cracked distillate

IUPAC Name:

Cracked distillate

Details on test material:

- Name of test material (as cited in study report): "Cracked distillate"
- Physical state: clear yellow/brown slightly viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someran, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2600-3050 g
- Housing: Individually in suspended, galvanised cages
- Diet: Standard laboratory rabbit diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 3°C
- Humidity: at least 40%
- Air changes: 10 per hr
- Photoperiod (hrs dark / hrs light): natural light cycle

IN-LIFE DATES: From: 22 May 1989 To: 25 May 1989

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: no corneal effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Remarks on result:

other: no iridial effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: minimal effects in 2 rabbits at 24 and 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: minimal effects in 2 rabbits at 24 and 48 hours

Any other information on results incl. tables

Eye irritation scores according to the Draize scheme

Time		Cornea			Iris			Conjunctiva
								Redness			Chemosis
	Animal number	5069	5071	5072	5069	5071	5072	5069	5071	5072	5069	5071	5072
after 1 hour		0	0	0	0	0	0	2	2	2	2	1	1
after 24 hours		0	0	0	0	0	0	0	1	1	0	1	1
after 48 hours		0	0	0	0	0	0	0	1	1	0	1	1
after 72 hours		0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72h		0	0	0	0	0	0	0	0.7	0.7	0	0.7	0.7

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Cracked Distillate is not irritating to the rabbit eye.

Executive summary:

The eye irritant potential of Cracked distillate (CAS 68477-40-7) was investigated in 3 albino rabbits. Slight or moderate redness and chemosis was seen in all three rabbits which recovered within 72 hours.

It can be concluded that Cracked distillate (CAS 68477-40-7) is not irritating to the rabbit eye and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.