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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 based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
From 1 March 1995 to 20 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Farmin TH

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: B&K UNIVERSAL G.J., S.L
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.3-2.5
- Housing: were individually in stainless steel cages with a grille floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 45-66
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye was used as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/animal
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours as well as 7, 14 and 21 days post exposure
Number of animals or in vitro replicates:
3
Details on study design:
The observation of the cornea was completed with the installation of an aqueous solution of 2% sodium fluorescein. This procedure involved the installation of the aqueous solution of fluorescein in the test area, followed by washing the area with a 0.9% physiological saline solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: exposure 24 hours
Irritation parameter:
iris score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure 24 hours
Irritation parameter:
conjunctivae score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: exposure 24 hours
Irritation parameter:
chemosis score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48 and 72 hours
Score:
3.11
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: exposure 24 hours

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.
Executive summary:

In an GLP compliant OECD TG 405 study, 100 mg the test substance Farmin TH (hydrogenated tallow alkyl amine), a white solid (pH = 9.93, purity 95%), was applied to the eyes of three New Zealand White rabbits. Pronounced conjunctiva redness and chemosis was observed throughout the entire observation period. Additionally, severe cornea opacity and moderate iris lesions was noted. Mean Draize scores for conjunctiva redness at 24, 48 and 72 hours were 3.0, 3.0 and 3.0. Mean scores for conjunctiva chemosis were 3.0, 3.0 and 3.3 for the same time points. These effects were not reversible within the observation period of 21 days. Related scores for iris were 1.0, 1.0 and 1.0, reversible between 14 and 21 days. Scores for cornea density were 3.0, 3.3 and 3.7, respectively and showed a value of 2.0 at the end of the observation period. Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.