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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 08.11.1988 to 21.11.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD guideline 405 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Camphene
EC Number:
201-234-8
EC Name:
Camphene
Cas Number:
79-92-5
Molecular formula:
C10H16
IUPAC Name:
2,2-dimethyl-3-methylidenebicyclo[2.2.1]heptane
Details on test material:
- Name of test material (as cited in study report): Camphen
- Substance type: solid
- Physical state: colorless, clear, vaseline-similar
- Analytical purity: 78,4 %
- Purity test date: 26.11.1987
- Lot/batch No.: 112
- Storage condition of test material: In the dark at 4 ºC in the refrigerator.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: ca. 3 - 5 Months old
- Weight at study initiation: 2.6 - 3.2 kg
- Housing: Individually housed in battery cages in air-conditioned rooms.
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat - Rabbit, Altromin GmbH, Lage / Lippe, ad libitum, and hay (about 15 grams daily).
- Water (e.g. ad libitum): Deionized, chlorinated water from automated drank, ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 50 ± 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 08.11.1988 to 15.11.1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye in each case served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With saline at ca. 37 ºC.
- Time after start of exposure: 24 hours after application

SCORING SYSTEM: Eyes observations were made 1, 24, 48 and 72 hours after test substance application. 24 and 72 hours after application, a drop of fluorescein sodium solution (0.01%) was instilled and the cornea examined under UV light for damage. Damage to the cornea, the iris and the conjunctiva were evaluated numerically. All other changes were recorded.
Opacity: degree of turbidity:
No ulceration or opacity ............................................................................................ 0
Scattered or diffuse areas of opacity (other than) slight clouding of the normal luster, details of iris clearly visible............. 1
Easily discernible translucent area, details of iris slightly shadowed.................. 2
Pearly areas, no details of iris visible, size of pupil barely discernible ............... 3
Opaque cornea, iris not discernible due to the opacity......................................... 4
Iris:
Normal........................................................................................................................... 0
Pronounced depth wrinkles, congestion, swelling, mild circumcorneal hyperemia or injection, any of these symptoms or a combination the various symptoms, the iris still reacts to light (sluggish reaction is positive) ..................... 1
No reaction to light, haemorrhage, severe damage (one or all symptoms)......... 2
Conjunctivae:
Redness: lids and / or nictitating
Normal blood vessels ........................................................................................ 0
Some blood vessels show a marked hyperemia (injection) ......................... 1
Diffuse crimson color, individual vessels not easily discernible ................ 2
Diffuse strong red .............................................................................................. 3
Conjunctivae
Chemosis: lids and / or nictitating
No swelling ........................................................................................................... 0
Any swelling above normal lying (including haw) .......................................... 1
Obvious swelling with partial eversion of lids ................................................ 2
Swelling, with roughly half-closed lids ............................................................ 3
Swelling with more than half-closed lids ......................................................... 4

TOOL USED TO ASSESS SCORE: Corneal examination with fluorescein sodium solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
1.3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
0.7
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
An hour to 48 hours post application, the conjunctiva of the animals showed a diffuse crimson red color to diffuse strong and a slight swelling to a swelling of about half-closed lids. The cornea showed diffuse areas of opacity to translucent easily recognizable. One hour and 24 hours post application, clear, colorless or with white mucous iris was observed. 72 hours post-application, in two animals, a diffuse crimson-red to bright red color and diffusely a slight swelling of the conjunctiva was observed. The cornea of an animal showed diffuse areas of opacity. 7 days post-application, all symptoms of irritation were reversible.

Any other information on results incl. tables

Based on the results registered, Camphene was considered as irritanting for the rabbits eyes. All symptoms were fully reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results registered, Camphene was considered as irritanting for the rabbits eyes. All symptoms were fully reversible within 7 days.
Executive summary:

This study has been carried out with the aim of evaluating the possible irritant / corrosive effects of Camphene on the eyes, using three white rabbits (New Zealand). Test method was according to OECD guidelines 405 and GLP.

A single dose of 100 mg was applied to the conjunctival sac of the right eye. The non-treated eye of each animal was used as control.

The irritation degree was daily registered for three days to be later scored in order to make a whole effect assessment.

During the assay period, environmental conditions remained constant (Temperature: 20 ± 3 ºC, Humidity: 50 ± 20 % and Photoperiod: twelve hours light and twelve hours darkness).

Based on the results registered, Camphene was considered as irritanting for the rabbits eyes. All symptoms were fully reversible within 7 days.