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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
27 Nov - 30 Nov 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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:
Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Constituent 1
Reference substance name:
Dodecanoic acid, ester with 1,2,3-propanetriol, acetylated
EC Number:
294-597-7
EC Name:
Dodecanoic acid, ester with 1,2,3-propanetriol, acetylated
Cas Number:
91744-35-3
IUPAC Name:
91744-35-3
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Chemical name: Acetylided glyceride-mixture
- Physical state: clear, slight yellowish fluid
- Analytical purity: 99.8%
- Lot/batch No.: CH70920C
- Expiration date of the lot/batch: 20 Sep 2008
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: Crl:KBL(NZW)BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually in cage units Metall/Noryl. Excrement trays below the cages contained low dust wood granulate bedding. The wood granulate was changed at least twice weekly. The animals were regularly transferred to clean cages. The animal room was provided with sound from a radio program.
- Diet: standard diet "Ssniff K-Z" 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approx. 100 g per animal per day. To satisfy the needs of roughage, hay was offered additionally (hay, irradiated, delivered by Harlan Winkelmann, Borchen, Germany; respectively hay pellets delivered by Ssniff Spezialdiäten GmbH, Soest, Germany).
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- 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 applied: 0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 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 over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
1 h post-instillation: moderate conjunctival redness and very slight chemosis were observed in all 3 animals. No corneal opacity or iritis was noted in any animal.
24 h post-instillation: slight conjunctival redness and very slight chemosis were observed in 3/3 and 2/3 animals, respectively. Both effects were fully reversible after further 24 h (48 h reading). No corneal opacity or iritis was noted in any animal.
48-72 h post-instillation: no eye effects were observed in any animal.
Other effects:
No further local effects were reported. There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit # Time [h] conjunctivae    iris cornea
redness swelling
1 1 2 1 0 0
24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0.0 0.0 0.0
2 1 2 1 0 0
24 1 1 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0.3 0.0 0.0
3 1 2 1 0 0
24 1 1 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0.3 0.0 0.0
   
Time [h] conjunctivae    iris cornea
  redness swelling    
average
score
1 2.00 1.00 0.00 0.00
24 1.00 0.67 0.00 0.00
48 0.00 0.00 0.00 0.00
72 0.00 0.00 0.00 0.00
24+48+72 0.33 0.22 0.00 0.00

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