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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-diethylaminopropiononitrile
EC Number:
226-323-9
EC Name:
3-diethylaminopropiononitrile
Cas Number:
5351-04-2
Molecular formula:
C7H14N2
IUPAC Name:
3-(diethylamino)propanenitrile
Details on test material:
- Name of test substance (as cited in study report): N,N-Diethylaminopropionitril
- Analytical purity: 99.6%
- Test substance number: 96/119
- Batch number: K80/1 Hauptlauf
- Physical state: liquid (colourless)
- Storage conditions: refrigerator

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HSDIF:NZW (SPF); Harlan Winkelmann GmbH, UK
- Age at study initiation: young adult animals
- Weight at study initiation: 3.38 kg (male); 3.28 kg and 3.86 kg (females)
- Housing: single housing in stainless stel wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugust, 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): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
one single application (rinsing after 24 h)
Observation period (in vivo):
8 days (readings: 1 h, 24 h, 48 h, 72 h and 8 d after application)
A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h after application

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System

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:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
(mean out of animal#2 and #3)
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(out of animal#2 and #3)
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
- 24 h: contracted pupil (3/3 animals), suppuration (1/3 animals) and bloody discharge (1/3 animals)
- 48 h: contracted pupil (1/3 animals) and suppuration (2/3 animals)
- 72 h: contracted pupil (1/3 animals), suppuration (3/3 animals) and loss of corneal tissue (3/3 animals)

Any other information on results incl. tables

Table 1: Eye irritation

Reading

Animal#

Cornea

Iris

Conjunctivae

Symptoms

OP

AR

RED

SW

DI

1 h

1

0

0

0

1

3

3

 

2

0

0

0

2

2

2

 

3

0

0

0

2

2

2

 

24 h

1

1

1

1

2

2

2

S, PC

2

1

1

1

3

2

1

PC

3

1

2

1

3

2

2

PC, DB

48 h

1

1

1

1

2

1

2

S, PC

2

1

1

0

3

2

1

 

3

1

1

0

3

2

2

S

72 h

1

1

1

1

3

2

2

S, PC, LC

2

1

1

1

2

2

0

S, LC

3

1

1

1

2

2

0

S, LC

8 d

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

Mean (24, 48 and 72 h)

1

1.00

 

1.00

2.33

1.67

 

 

2

1.00

 

0.67

3.00

2.00

 

 

3

1.00

 

0.67

2.67

2.00

 

 

Mean (3 animals)

 

1.00

 

0.78

2.67

1.89

 

 

OP = opacity

AR = area

RED = redness

SW = swelling

DI = discharge

S = suppuration

PC = pupil contracted

DB = discharge of blood

LC = loss of corneal tissue

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information category 2