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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of the test substance: Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese)
- Substance number: 98/417-1
- Batch number: 29003-138
- Degree pf purity/content: 96.2 g/100 g (H-NMR spectroscopy)
- Date of manufacturing: 1998-09-14
- Physical state/appearance: viscous, colourless-clear
- Storage conditions: room temperature, exclusion of light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 3.6 - 3.89 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Controls:
other: untreated eye
Amount / concentration applied:
0.1 mL (unchanged)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: for information on the scoring system see below: "Attached background material".

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
other: animal 1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
other: animal 1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
chemosis score
Basis:
other: animal 1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0

Applicant's summary and conclusion

Executive summary:

Under the test conditions chosen and considering the described findings Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese) does not give indication of an irritant property to the eye.