Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reporting, but data condsidered adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Report Date:
1966
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited reporting (only very brief details on test method and results)
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): "40% chlorinate of C10-13 normal paraffin"
- Substance type: technical product
- Physical state: white liquid
- Analytical purity: no data
- Impurities (identity and concentrations): 1% Abrac A (epoxydised soya oil) added as a stabliser
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (40% chlorination)
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.:
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- 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
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): "one drop" [presumably about 0.1 ml]

Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
no data

Results and discussion

In vivo

Results
Irritation parameter:
other: no scores given, description of physical signs only
Basis:
other: all animals
Time point:
other: 24 h
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: mild congestion seen at 1 h which had completely resolved by 24 h
Irritant / corrosive response data:
No immediate reaction, but mild congestion seen at 1 h which had completely resolved by 24 h.
Other effects:
no data

Any other information on results incl. tables

No irritation scores given.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
When applied to the right eye of each of three rabbits, a C10-13 chlorinated paraffin (40% chlorination) caused mild congestion after 1 h, which had completely resolved within 24 h.
Executive summary:

In an assessment of its potential to induce eye irritation, a drop of undiluted C10-13 chlorinated paraffin (40% chlorinatation) was placed into the right eye of each of three rabbits and observations were made over a 3-day period. Mild congestion was evident after 1 h but this had completely resolved within 24 h.

Under the conditions of this study, this C10-13 chlorinated paraffin would not be classified as an eye irritant according to EU CLP and DSD regulations.