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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Observation period could have been extended to fully observe reversal of effects.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.5
Principles of method if other than guideline:
Observation period was only 7 days.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-12
EC Number:
271-642-9
EC Name:
Alcohols, C6-12
Cas Number:
68603-15-6
IUPAC Name:
octan-1-ol
Details on test material:
Tradename Lial 111 C6-12 alcohols Type A

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
unspecified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: direct observation and UV lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.11
Max. score:
1.3
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
- Conjunctivae (Redness): individual scores all 2 (group mean score 2)
- Conjunctivae (Chemosis): individual scores 4 rabbits 1, 2 rabbits 1.3  (group mean score 1.11)

REVERSIBILITY: Conjunctival redness and chemosis persisted to 7 days.  Individual scores for redness were 4 rabbits grade 1, 2 rabbits 0 
(group  mean score 0.66) and for chemosis wer 3 rabbits grade 1, 3 at 0 (group  mean score 0.5)
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Using EU criteria Lial 111 is a category 2 irritant based on 24+48+72 hour scores for conjunctival redness of 2 in all rabbits and persistence to 7 days. The evidence of conjunctival irritation at 7 days was noticeably less than at 72 hours.

Classification: not irritating