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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Solvent naphtha (petroleum), light arom.
EC Number:
265-199-0
EC Name:
Solvent naphtha (petroleum), light arom.
Cas Number:
64742-95-6
IUPAC Name:
64742-95-6
Constituent 2
Reference substance name:
Shellsol A
IUPAC Name:
Shellsol A
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.