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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in accordance with GLP

Data source

Reference
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
BASF AG, Department of Toxicology

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritoltetracyanoacetic ester
EC Number:
605-830-2
Cas Number:
178671-69-7
Molecular formula:
C17 H16 N4 O8
IUPAC Name:
Pentaerythritoltetracyanoacetic ester

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: 3.43 - 3.65 kg
- Housing: Single housing in Stainless steel wire mesh cages with grating, floor area: 3000 cm squared
- Diet: Kliba-Labordiät, Klingentalmühle AG Kaiseraugst, Switzerland, (about 130 g per animal per day)
- Water: 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

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24 - 72 hr
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24 - 72 hr
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24 - 72 hr
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: irritation score of 1 after 1 hour after treatment observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: mean 24 - 72 hr
Score:
0
Max. score:
4
Remarks on result:
other: all scores for chemosis were zero
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: mean 24 - 72 hr
Score:
0
Max. score:
4
Remarks on result:
other: all scores for cornea reactions were zero
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: mean 24 - 72 hr
Score:
0
Max. score:
2
Remarks on result:
other: all scores for iris reactions were zero
Irritant / corrosive response data:
Only minimal reddening of the conjunctivae observed, reversible within 24 (in one animal) and 72 ( in two animals) hours.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means.

Readings Animal Cornea  Iris Redness Chemosis
1h 1 0 0 1 0
2 0 0 1 0
3 0 0 1 0

24 h

 1 0 0 1 0
2 0 0 1 0
3 0 0 0 0
48 h 1 0 0 1 0
2 0 0 1 0
3 0 0 0 0
72 h 1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
Mean 1 0 0 0.7 0
2 0 0 0.7 0
3 0 0 0 0
Mean   0 0 0.4 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen and considering the described findings the test compound does not give any indication of an irritant property to the eye.
Executive summary:

In an acute eye irritation study performed according to OECD guideline no. 405 and in compliance with GLP, the potential of the test compound to cause damage to the conjunctivae, iris and cornea was assessed in 3 New Zealand White rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 36 mg) of the test substance. The average score (24 - 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application. Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye.