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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reporting; however study considered adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rabbits were given a single application of a C14-17 chlorinated paraffin (chlorinated to either 40 or 45%) into the conjunctival sac of one eye and observed for up to 7 days.
GLP compliance:
no
Remarks:
Prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Meflex DC024 and Meflex DC029
- Substance type: technical product
- Physical state: pale yellow liquid
- Impurities (identity and concentrations): 0.2% epoxy soya bean oil; 0.3% lubrizol LZ55A; 0.3% polyethylene glycol; 0.2% NonoxWSL
- Composition of test material, percentage of components: Meflex DC024; a C14-17 n-paraffin, chlorinated to 40%. Meflex DC029; a C14-17 n-paraffin, chlorinated to 45%
- Stability under test conditions: "good"
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: no data- Age at study initiation: no data- Weight at study initiation: 2.5 to 3.5 kg- Housing: no data- Diet (e.g. ad libitum): no data - Water (e.g. ad libitum): no data- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: From: To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
" One drop"
Duration of treatment / exposure:
No indication given as to whether the applied material was washed out of the eye after instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Initial pain assessed on 6 point scale and irritation asseessed as described by Draize (1959) and interpreted as described by Kay and Calandra (1962)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1-2 hr
Score:
3.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Meflex DC024/Meflex DC029
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
80
Reversibility:
not specified
Remarks on result:
other: Meflex DC024/Meflex DC029
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
80
Reversibility:
not specified
Remarks on result:
other: Meflex DC024/Meflex DC029
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-2 hr
Score:
3.3
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: Meflex DC024/Meflex DC029
Irritant / corrosive response data:
Both materials caused slight, transient conjuctivitis (score 3 on 1-8 scale)
Other effects:
Pain score at instillation - 2 (scale 0-5)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated informationCriteria used for interpretation of results: expert judgment
Conclusions:
When instilled into the conjunctival sac of one eye of each of three rabbits, a single drop of Meflex DC024 (an epoxy stabilised C14-17 chlorinated paraffin; 40% chlorination) and Meflex DC029 (an epoxy stabilised C14-17 chlorinated paraffin, 45% chlorinated) produced no iridial or corneal effects over an observation period of 7 days and only mild, transient conjunctival effects.
Executive summary:

Meflex DC024 (an epoxy stabilised C14-17 chlorinated paraffin; 40% chlorinated) and Meflex DC029 (an epoxy stabilised C14 -17 chlorinated paraffin, 45% chlorinated) were assessed for their ability to cause eye irritation and corrosion by instilling one drop of the undiluted material into the conjunctival sac of one eye of each of three rabbits.

Slight initial pain (score 2 on a 6 -point scale) was noted after instillation. No iridial or corneal effects were seen up to 7 days post administration and only transient conjunctival irritation (score 3 out of 8 for conjunctival effects) was seen at 1 -2 hr post instillation.

Under the conditions of this study, Meflex DC024 and Meflex DC029 were judged to be slight eye irritants and would not be classified as capable of producing serious eye damage/eye irritation under the EU CLP and DSD regulations.