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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:
1984-05-30 - 1984-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted study similar to guideline (limited documentation, no specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation, not specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, 2-hexyldecyl esters
EC Number:
309-832-1
EC Name:
Fatty acids, C16-18, 2-hexyldecyl esters
Cas Number:
101227-09-2
IUPAC Name:
101227-09-2
Details on test material:
- Name of test material (as cited in study report): Isohexadecylstearat
No further details provided

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 4420 g
No additional details provided.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Not specified (contact period was reported to be 10 s)
Observation period (in vivo):
48 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

SCORING SYSTEM: the irritation (cornea, iris, conjuctivae) reaction were scored in percentage of the maximal possible reaction, but no discrimination was done for conjunctivae reaction (swelling or redness).
The results are therefore evaluated in a worst case approach, by attributing the full reported reactions (percentages, as described above) equally to conjunctivae redness and to conjunctivae swelling. The percentages will be converted to the OECD guideline scores as follows: 1) for conjunctivae redness, up to 100% will be considered to correspond to a OECD score of 3, up to 66% to 2 and up to 33% to 1); for conjunctivae swelling, up to 100% will be considered to correspond to a swelling score of 4, up to 75% to 3, up to 50% to 2, and up to 25% to 1.

TOOL USED TO ASSESS SCORE: not specified.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: 24-48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: 24-48 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of all animals
Time point:
other: 24-48 hours
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: 24-48 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
Irritant / corrosive response data:
Neither cornea nor iris reactions were observed up to the end of the observation period. A moderate conjunctivae reaction was observed from 1 hour after treatment, but was completely reversible within 48 hours observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information