Hydrocarbons, steam-cracking tar middle

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Residues (petroleum), steam-cracked

EC Number:

265-193-8

EC Name:

Residues (petroleum), steam-cracked

Cas Number:

64742-90-1

IUPAC Name:

64742-90-1

Constituent 2

Reference substance name:

Carbon Black-DSM Roetolie

IUPAC Name:

Carbon Black-DSM Roetolie

Details on test material:

- Name of test material (as cited in study report): Carbon Black-DSM Roetolie
- Batch number: UN:2810, batch number. 16-5-89
- Substance type: Mixture of high boiling aromatic hydrocarbons
- Physical state: dark brown viscous liquid
- Analytical purity: not applicable
- Storage: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Sex: male
- Weight at study initiation: 2700-2870 g
- Housing: individually in suspended, galvanized cages, fitted with a wire mesh floor and front
- 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 (per hr): approx. 10
- Photoperiod: natural day/night cycle

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

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

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Corneal opacity on a 0-4 scale, iritis on a 0-2 scale, conjunctival redness on a 0-3 scale, conjunctival chemosis on a 0-4 scale

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:

4

Remarks on result:

other: no corneal effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 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, 72 hours

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: minimal redness in 3 animals 1- 24 hours and 1 animal at 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: minimal chemosis in 3 animals 1- 24 hours and 1 animal at 48 hours

Irritant / corrosive response data:

After 1 hour slight redness with or without slight swelling of the conjunctivae. At 24 hours slight redness and slight swelling of the conjunctivae. At 48 hours the eye effects had cleared completely in two of the three rabbits, whereas slight redness and slight swelling of the conjunctivae were observed in the third rabbit. All irritation had cleared by 72 hours.

Other effects:

The test substance adhered to the hair surrounding the eye in all 3 rabbits.

Any other information on results incl. tables

Eye irritation scores of Carbon Black-DSM Roetolie

Time		Cornea			Iris			Conjunctiva
								Redness			Chemosis
	Animal number	63	73	74	63	73	74	63	73	74	63	73	74
after 1 hour		0	0	0	0	0	0	1	1	1	1	0	0
after 24 hours		0	0	0	0	0	0	1	1	1	1	1	1
after 48 hours		0	0	0	0	0	0	0	0	1	0	0	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	0.3	0.3	0.7	0.3	0.3	0.7

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Carbon Black-DSM Roetolie is not irritating to eyes.

Executive summary:

Eye irritation potential of carbon black-DSM Roetolie (CAS 64742-90-1) was determined in a group of three albino rabbits.

There was no evidence of damage to the cornea or iris throughout the study. Conjunctival redness and chemosis was seen from 1 hour to 48 hours after application. Mean scores over 24, 48 and 72 hours were: cornea 0, iris 0, conjunctival redness 0.4, chemosis 0.4.

Carbon black-DSM Roetolie (CAS 64742-90-1) was not irritating to the rabbit eye and does not warrant classification under Dir 67/548/EEC or GHS CLP.