Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 10 November 1980 To 17 November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2c Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 40 CFR Part 163.81-' (Environmental protection agency pesticide programs. Proposed guidelines for registering pesticides in U.S.; hazard evaluation: humans and domestic animal. Primary eye irritation study)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanal
EC Number:
203-898-4
EC Name:
Heptanal
Cas Number:
111-71-7
Molecular formula:
C7H14O
IUPAC Name:
heptanal
Details on test material:
- Name of test material (as cited in study report): C-191
- Substance type: C7 aldehyde
- Physical state: colorless liquid
- Analytical purity: no data
- Purity test date: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: SN 2213-2
- Expiration date of the lot/batch: no data
- Storage condition of test material: Room temperature (stored under nitrogen blanket)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Denver, Pennsylvania.
- Age at study initiation: young adults
- Weight at study initiation: 2.1 to 2.9 kg
- Fasting period before study: no data
- Housing: individual
- Diet : ad libitum, Purina Rabbit chow.
- Water : ad libitum.
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 10 November 1980 To: 17 November 1980

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the lower conjunctival sac of the right eye of each animal.



Duration of treatment / exposure:
The treated and control eyes of six animals remained unwashed.
Twenty seconds after the test substance was administered, both eyes of the remaining three animals were rinsed for one minute with lukewarm water.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 (6 unwashed, 3 rinsed after 20 seconds of exposure)
Details on study design:
REMOVAL OF TEST SUBSTANCE in 3/9 animals
- Washing (if done): lukewarm water
- Time after start of exposure: twenty second


SCORING SYSTEM:
According to the Draize scale


Cornea
Opacity: degree of density (area most dense taken for reading)*
No opacity........................................................................................................................................... 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
details of iris clearly visible .............................................................................................................. 1
Easily discernible translucent area; details of iris slightly obscured .........................................2
Nacreous area; no details of iris visible; size of pupil barely discernible ..................................3
Complete corneal opacity; iris not discernible ..............................................................................4
Maximum possible: 4

Iris
Normal......................................................................................................................................................0
Markedly deepened folds, congestion, swelling, circumcorneal injection;
(any of these or combination of any thereof).....................................................................................1
No reaction to light, hemorrhage, gross destruction (any or all of these)....................................2
Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Vessels normal ................................................................................................................................0
Some vessels definitely injected ...................................................................................................1
Diffuse, crimson red; individual vessels not easily discernible ...............................................2
Diffuse beefy red..............................................................................................................................3
Maximum possible: 3

Chemosis
Swelling (refers to lids and/or nictating membranes)
No swelling.........................................................................................................................................0
Any swelling above norma (includes nictitating membrane).....................................................1
Obvious swelling, with partial eversion of lids.............................................................................2
Swelling, with lids about half closed ..............................................................................................3
Swelling, with lids more than half closed ......................................................................................4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
6 rabbits unwashed
Time point:
other: 24, 48 and 72 hours
Score:
1.9
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 2 animals with a score > or = 2
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Remarks:
6 rabbits unwashed
Time point:
other: 24, 48 and 72 hours
Score:
1.55
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 2 animals with a score > or = 2
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits unwashed
Time point:
other: 24, 48 and 72 hours
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 animal with a score > or = 1
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
6 rabbits unwashed
Time point:
other: 24, 48 and 72 hours
Score:
0.95
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 3 animals with a score > or = 1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: 3 rabbits "washed"
Remarks:
3 rabbits "washed"
Time point:
other: 24-48-72 hours
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: All 3 animals with a score > or = 2
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Remarks:
3 rabbits "washed"
Time point:
other: 24-48-72 hours
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0 animal with a score > or = 2
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits "washed"
Time point:
other: 24-48-72 hours
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0 animal with a score > or = 1
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
3 rabbits "washed"
Time point:
other: 24-48-72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0 animals with a score > or = 1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within:
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
All nine rabbits exhibited positive scores for conjunctival redness, chemosis and necrosis. Four of the six animals with unwashed eyes exhibited positive scores for corneal opacity and ulceration, and five animals had iridial irritation. Two of the three animals with washed eyes showed positive scores for iridial irritation and corneal ulceration, and one exhibited a positive for iridial and corneal ulceration, and one exhibited a positive score for corneal opacity. All eyes were free of irritation by Day 7.
Other effects:
None.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility  Cornea
Max. score: 4
Iris
Max. score: 2
Conjunctivae
Max. score: 3
Chemosis
Max. score: 4
24 h 2/0/2/2/0/1 1/0/1/1/1/1 2/2/2/3/2/2 2/2/3/3/2/3
48 h 2/0/1/2/0/1 1/0/0/1/0/1 2/2/2/3/2/2 1/1/2/2/1/2
72 h 2/0/0/2/0/0 0/0/0/1/0/0 2/0/1/3/1/1 1/0/1/1/1/0
Days 4 1/0/0/0/0/0 0/0/0/0/0/0 2/0/0/2/0/0 1/0/1/1/1/0
Days 7 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Mean scores over 24, 48 and 72 hours for each animal 2/0/1/2/0/0.66 0.66/0/0.33/1/0.33/0.66 2/1.33/1.66/3/1.66/1.66 1.33/1/2/2/1.33/1.66
Average 24h, 48h, 72h calculated over all the animal tested 0.94 0.5 1.88 1.55
Reversibility*) c. c. c. c.

*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information but not classified Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Under the conditions of this test, the substance is considered as slightly irritating and is not classified according to EU and CLP classification.
Executive summary:

In an ocular irritation test (Bio/dynamics Inc., 1980), nine albino New Zealand white rabbits were used. The test substance (heptanal) was introduced into the lower conjunctival sac of the right eye of each animal. The animal's left eye served as a control. The treated and control eyes of six animals (3 females and 3 males) remained unwashed. Twenty seconds after the test substance was administered, both eyes of the remaining three animals (2 females and 1 male) were rinsed for one minute with lukewarm water. Animals were observed for 7 days. Irritation was scored following a grading of ocular lesions similar to that of the guideline OECD 405. After 24 hours all rabbits (washed and unwashed) showed chaemosis and redness reactions. Most of these effects decreased after 24 hr and desappeared totally after 4 or 7 days. Iris and corneal reactions were also reported in some animals (washed and unwashed). The scores (mean: 24, 48 and 72 hr scores) calculated over all the unwashed animal tested for chemosis, redness of conjunctivae, iris lesion and cornea opacity were respectively 1.55, 1.88, 0.5 and 0.94. Eye observed reactions were fully reversible within 4 or 7 days in all animals. Under the conditions of this test, the tested substance is considered as slightly irritating and is not classified according to EU and CLP classification.

Categories Display