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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
06 - 16 Aug 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, UK

Test material

Constituent 1
Chemical structure
Reference substance name:
C36 fatty diol
EC Number:
604-608-2
Cas Number:
147853-32-5
Molecular formula:
not available UVCB
IUPAC Name:
C36 fatty diol
Details on test material:
- Name of test material (as cited in study report): Dimerdiol
- Physical state: clear, colourless liquid
- Substance type: UVCB
- Analytical purity: 100%
- Composition of test material, percentage of components: monomeric alcohol, 1%; dimer alcohol, 90.8%, dimer (1.5-mer incl.) alcohol, 96%; trimer alcohol, 3%
- Purity test date: 27 May 2011
- Lot/batch No.: 558516
- Expiration date of the lot/batch: 14 May 2013
- Storage condition of test material: at room temperature in the dark
- pH: approx. 8 (undiluted as supplied and as 90% v/v aqueous preparation)

Test animals / tissue source

Species:
rabbit
Strain:
other: Hsdlf:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.15 and 3.28 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required, the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
2 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

EXAMINATIONS

CLINICAL SIGNS: clinical signs of toxicity, if present, were also recorded.

BODY WEIGHT: Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in both treated eyes 1 and 24 h after treatment and in one treated eye at the 48 h observation. Minimal chemosis was noted in both treated eyes 1 h after treatment persisting in one treated eye at the 24 h observation. Minimal discharge was noted in both treated eyes at the 1 h observation.
One treated eye appeared normal at the 48 h observation and the other treated eye appeared normal at the 72 h observation.
Other effects:
No further local or systemic effects were reported.
No gain in body weight was noted in one animal and bodyweight loss (-20 g) was noted in the other animal during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified