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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:
weight of evidence
Study period:
1963
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method similar to a recognised OECD guideline. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
not reported

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not reported
Duration of treatment / exposure:
Each animal had 0.1 ml of the test sample instilled into the right eye with no further treatment. The untreated left eye of each animal served as its
own control.
Observation period (in vivo):
Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
The scorings recorded were made according to the Draize scale for scoring ocular lesions.

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1,2,3,4,7 d
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1,2,3,4,7 d
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1,2,3,4,7
Score:
11.3
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
12
Remarks on result:
other: n=3; maximum category score =4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: n=3; maximum category score = 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.33
Max. score:
9
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: n=3 ; maximum category score = 3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.22
Max. score:
12
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: n=3; maximum category score = 4
Irritant / corrosive response data:
No corneal opacityor iris congestion was observed. A diffuse redness of the vessels of the palpebral conjunctivae did occur. This injection was accompanied by a partial eversion of the lids and some discharge. On the 7th day observation of the conjuncitvae was normal.

Any other information on results incl. tables

Applicant recalcluated the scoring to the EU/GHS scoring criteria. Individual scoring was presented within the study report.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material is considered to be irritating the eyes of albino rabbits.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye following a single application in albino white rabbits. The pre-GLP study was completed under a method similar to OECD 405. A volume of 0.1 ml of the test material was placed into one eye of 3 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made every 24 hour for 4 days and again on day 7 using scoring based on the Draize scale for scoring occular lesions. Instillation of the test material did not produce any corneal opacity or iris congestion. A diffuse redness of the vessels of the palpebral conjunctivae did occur. This injection was accompanied by a partial eversion of the lids and some discharge. On the seventh day of observation the conjunctivae were normal in all test animals. Under the conditions of this study the test material is considered to be irritating the eyes of albino rabbits.