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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: other: An amount of 0.1 ml of test material was instilled in the conjunctival sac of the right eye. The upper and lower lids were then held together for 1 second. The left eye was untreated and served as the control.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C10-16
EC Number:
267-019-6
EC Name:
Alcohols, C10-16
Cas Number:
67762-41-8
IUPAC Name:
tetradecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).

- Physical state: clear transparent liquid

- Storage condition of test material: at ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adults
- Weight at study initiation:1870-2132g
- Housing: individually housed in stainless stel cages with perforated floor
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-82.5
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single instillation, not washed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3M
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: According to guideline

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
All scores at 24/48/72 hours were 0 in all animals.
At 1 hour after treatment, slight redness of the  conjunctivae (grade 1 vessels definitely injected) was observed in all  animals.  At 24, 48, and 72 hours, no signs of eye irritation were  observed in any of the 3 animals. Fully reversible in the 72 hour observation period.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A) is not an eye irritant according to EU or GHS criteria.

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