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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study, since in vitro studies were not available at that time
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2007-11-26 to 2007-12-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is a well-documented study report that followed OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Paraffin Wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))
IUPAC Name:
Paraffin Wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))
Details on test material:
Read Across to Paraffin and Hydrocarbon Wax
- Name of test material (as cited in study report): Paraffin waxes (Fischer - Tropsch), full range, C15-50- branched and linear
- Substance type: Paraffin wax and Hydrocarbon Wax
- Physical state: turbid colourless liquid
- Storage condition of test material: room temperature in the dark under nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Oxon, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 air changes pe rhour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 2007-11-26 to 2007-12-06

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single dose followed by observation period of 72 hours
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): none
- Time after start of exposure: none

SCORING SYSTEM:
Eyes were scored at 1, 24, 48, and 72 hours using an initial pain reaction scale and then the modified Kay and Calandra system.

Score for conjunctivae = (A + B + C) x 2, maximum score = 20
Score for iris = D x 5, maximum score = 10
Score for cornea = (E x F) x 5, maximum score = 80

where A = redness, B = chemosis, C = discharge, D= iris involvement, E = degree of opacity, F = area of cornea involved


TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
80
Remarks on result:
other: Unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
10
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
20
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
No corneal or iridial effects were observed. Slight conjunctival irritation was noted in all treated eyes at one and 24 hours after treatment. All eyes appeared normal at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Paraffin wax is considered not irritating. Slight conjunctival irritation was observed at 1 and 24 hours after treatment and fully reversible after the 24 hour timepoint.
Executive summary:

Read across justification

No eye irritation studies have been reported for petrolatum (non-carcinogenic feed-stock), but data has been reported for paraffin and hydrocarbon waxes, materials similar to petrolatum (non-carcinogenic feed-stock).

In a primary eye irritation study, 0.1 millilitres of paraffin wax was instilled into the conjunctival sac of three male New Zealand White rabbits whose eyes were unwashed. Animals then were observed for 72 hours. Irritation was scored by the method of Draize and a modified Kay and Calandra interpretation of the eye irritation test. Results are presented in the Draize method of scoring.

           

Slight conjunctival irritation was observed at 1 and 24 hours after treatment and fully reversible after the 24 hour timepoint.In this study, paraffin wax is not an eye irritant based on minimal conjunctival irritation (maximum score of 2 based on redness in each animal) at 24 hours which was fully reversible after the 24 -hour observation.          

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD Guideline 405.