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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-05-23 to 1989-05-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Witamol 118
- Physical state: liquid
- Analytical purity: approx. 99 %
- Lot/batch No.: 890 205

- Molecular formula (if other than submission substance): C25 H40 O4
- Molecular weight (if other than submission substance): 404.60
- Smiles notation (if other than submission substance): CCCCCCCCCOC(=O)c1ccccc1C(=O)OCCCCCCCC

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm phyiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.11
- Conjuntivae (Chemosis): 0.0
Other effects:
Minimal to slight discharge was observed in two animals only one hour after application.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

 0/0/0

 1/1/1

 0/0/0

24 h

 0/0/0

 0/0/0

 0/1/0

0/0/0 

48 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

72 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

Average 24h, 48h, 72h

 0

 0

 0.11

 0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

 -

 -

 c.

 -

Average time (unit) for reversion

 -

 -

 48 hours

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Witamol 118 showed a slight irritating effect on the eyes of rabbits.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the rabbit and was designed to comply with the requirements of the OECD Guidelines of Testing of Chemicals No. 405.

WITAMOL 118 was administered undiluted to the eye rabbits as a single application and produced a slight irritating effect.