Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-11-24 - 1983-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Isophorone diamine, purity: 99.70 %
0.14 % isophorone aminonitril
0.12 % N-methyl isophorone diamine

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian
Details on test animals or tissues and environmental conditions:
- Sex: female
- Source: Dr. Karl Thomae, Biberach
- Weight at study initiation: 2.3 kg
- Sex: female
- Weight at study initiation: 2.8 kg
- Controls: untreated eye
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Controls: right eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
Postexposure period: 24 hours
Number of animals or in vitro replicates:
1
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 hours
Score:
110
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: Due to the strong corrosive effects of the test substance Isophorone diamine a scoring was not possible and therefore not reported (details see in section "Remarks on results including tables and figures")
Irritant / corrosive response data:
The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment
conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.
Other effects:
no other effects

Any other information on results incl. tables

Due to the strong corrosive effects of the test substance Isophorone diamine a scoring was not possible and therefore not reported. The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.

Applicant's summary and conclusion

Conclusions:
Isophorone diamine showed a strongly irritant and corrosive effect on the eye and on the mucosa of the rabbit under the conditions of the study.
Executive summary:

Isophorone diamine was investigated for irritant effects on the eye and associated mucous membranes of 1 female rabbit according to OECD TG 405 (1981). The test substance was applied in a single dose of 0.1 ml into the conjuntival sac of the animal. The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.The lesions were not reversible. Therefore Isophorone diamine has to be considered to be corrosive.