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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1989, july 14th to 1989, july 29th
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
EC Number:
406-200-8
EC Name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
Cas Number:
117827-06-2
Molecular formula:
C24H39Cl2NO2
IUPAC Name:
N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
Details on test material:
Description : White powder
Batch Number : Not indicated by the sponsor
Purity : 98,5%
Bulk Density : 0.7 g/ml
Instructions for test article storage : At room ternperature in the dark in a tightly sealed container
Stability of test article : Stable for one year maximal under storage conditions; expiry date: .January 5, 1990
Safety precautions : Gloves, goggles and face mask were considered sufficient to ensure personnel health and safety.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST SYSTEM
Species : Rabbit, New Zealand White (SPF—Quality)
Rationale : Recognised by international guidelines as the recommended test system (e.g. EPA, OECD, EEC).
Original Source : Charles River Wiga, Sulzfeld, West—Germany.
Total number of animals : 3 females
Age at start of treatment : Approx. 10 weeks
Body weight at start of treatment : 2846 — 3037 gram
Identificati on : Ear tag.
Acclimatisati on : At least five days under test conditions
HUSBANDRY
Room No.: 9
Conditions
Standard Laboratory Conditions. Air—conditioned with 7.5—15 air changes per
hour and hourly monitored environment with temperature 21 ± 3°C, relative
humidity 30—85 %, 12 hours artificial fluorescent light / 12 hours dark.
Accommodation
Individually in cages with perforated floors and equipped with an automatic
drinking system (ITL, Bergen, The Netherlands).
Diet
Pelleted standard LKK—20 rabbit maintenance diet (Hope Farms, Woerden, The
Netherlands) approx. 100 g per day. Certificates of analysis are retained in
the RCC NOTOX archives.
Water
Free access to tap—water, diluted with decalcified water. Certificates of’
analysis of tap—water are retained in the RCC NOTOX archives.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
70 ± 1 mg (equivalent to 0.1 ml)/ animal.
Duration of treatment / exposure:
The solid test article was ground to a powder prior to administration and was
applied undiluted as delivered by the sponsor.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
The following numerical scoring system was used to score the eye lesions:
CORNEA
Opacity: degree of density (area most dense taken for reading)
No ulceration or 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 areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Area of cornea affected
No ulceration or opacity 0
One quarter or less but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
IRIS
Normal o
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or any
combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reacticn to light, haemorrhage, gross destruction (any or all of these) 2
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris):
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis: lids and/or nictating membrane
No swelling 0
Any swelling above norrnal (includes nictating 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
Discharge:
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs, just adjacent to lids 2
Discharge with moistening of the lids and hairs, in a considerable area around the eye 3
In case standard lighting was considered inadequate for observing minor
effects, eye examinations were perf’orrned using a pocket flash light.
INTERPRETATION OF RESULTS
The irritation scores and all other observations were recorded on data sheets and transcribed for compilation and analysis.
A Draize score was calculated for each day of observation, using the following formula (Draize et al., 3. Pharmacol. Exp. Ther. 82, 1944):
(5x corneal opacity grade x area of opacity grade) + (5x iridial injury grade) +
2x (conjunctival redness grade + chemosis grade + discharge grade).
With the maximum score of the study (i.e. Draize score) a Kay and Calandra
interpretation was obtained, using the table below and taking into account the
time needed for healing (3. Society of Cosrnetic Chemists, Vol. B no. 6, 1962):
Draize score Tentative eye irritation rating to Kay and Calandra.
0 — 0.5 Non—irritating N
0.5 — 2.5 Practically non—irritating PN
2.5 — 15 Minimally irritating Ml
15 — 25 Mildly irritating M2
25 — 50 Moderately irritating M3
50 — 80 Severely irritating S
80 — 100 Extremely irritating E
100 — 110 Maximally irritating Mx
For borderline scores choose the higher rating.
The test resuits were evaluated according to the EEC general classification
and labelling requirements for dangerous substances (Annex VI of the EEC
Council Directive 67/548/EEC as amended by Directive 83/467/EEC, September,
1983).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
The test article appeared to be minimally irritating (Ml) to the rabbit eye
(Kay and Calandra interpretation of the Draize score: 4).
Instillation of UC—136 into one of the eyes of each of three albino rabbits affected the conjunctivae.
The irritation of the conjunctivae was reversible within 48 hours.
Treatment of the eyes with fluorescein 2%, 24 hours after test article
instillation revealed no corneal epithelial damage in any of the animals.
Other effects:
COLOURATION
No staining of the eyes by the test article was observed.
CORROSION
No corrosion was observed.
TOXIC SYMPTOMS / MORTALITY
No toxic syrnptoms were observed in the animals during the test period and no
mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, UC—136 resulted in adverse effects on the
conjunctivae. The irritation of the conjunctivae was reversible within 48 hours.
No corrosion nor signs of systernic intoxication were observed.
The test article should be considered minimally irritating (Ml) to the rabbit
eye (Kay and Calandra interpretation of’ the Draize score : 4).