Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Shellsol A
- Substance type: hydrocarbon solvent (essentially C9 isomers, particularly trimethylbenzenes)
- Physical state: liquid
- Source: Shell Nederland Raffinarderij B.V. refinery, Pernis, Rotterdam, The Netherlands

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Ranch Rabbits, Crawley, Sussex, UK
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.2 mL undiluted Shellsol A
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 male and 2 female
Details on study design:
Shellsol A instilled into conjunctival sac of right eye, untreated left eye served as a control. Eye irritation assessed 1, 2, 3 and 7 days after instillation according to numerical scheme cited in Federal Register (28 (110), 6.6.1963. para 191.12. Test for eye irritation)

Results and discussion

In vivo

Results
Irritation parameter:
other: Cornea, iris, and conjuctiva score
Basis:
animal: Range from all animals
Time point:
other: 30 min
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritant / corrosive response data:
Thirty minutes after instillation, slight to moderate conjunctival redness was present in all 4 rabbits and slight to moderate chemosis was present in 3 rabbits. Conjunctival discharge was present in one rabbit at the 30 minute and day 1 reading but did not persist. These conjunctival effects did not persist, no chemosis was seen after 1 day, very slight redness was seen in 2 rabbits at 1 day but all redness had cleared by day 2. There were no corneal or iridial effects.
Other effects:
There was an immediate pain reaction following instillation into the eye.

Any other information on results incl. tables

Eye irritation scores of Shellsol A

Time

Cornea

Iris

Conjunctiva

 

 

 

 

Redness

Chemosis

 

Animal number

9

10

56

57

9

10

56

57

9

10

56

57

9

10

56

57

after 30 mins

0

0

0

0

0

0

0

0

2

1-2

1

1

2

1

0-1

0

after 1 day

0

0

0

0

0

0

0

0

0-1

0

0-1

0

0

0

0

0

after 2 days

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

after 3 days

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

after 7 days

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Shellsol A was practically non-irritating to the rabbit eye.
Executive summary:

One drop (0.2 mL) of Shellsol A instilled into the rabbit eye caused an immediate pain reaction but thereafter was practically non-irritating.