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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From Jan. 7, 1980 to Feb. 8, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study design appears to follow OECD guideline 405 (2002) with deviations. Study report states that the procedure used was described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The substance is an analogue with a longer alkylchain.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
-reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
-report does not specify pH or whether the test material was ground to a fine dust as recommended for solids; the eye was rinsed after 30 sec in 3/6 animals rather than the recommended 1 hr (additional deviations listed in materials and methods section)
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: off-white powder
- Lot/batch No.: 4/79

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred and raised on the premises [CIBA-GEIGY Limited (Exp. Toxicology Sisseln GU 2.1, Basle, Switzerland)]
- Age at study initiation: adult, exact age not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 hrs dark/10 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Time after start of exposure: Approximately 30 seconds after treatment (in 3 of the 6 rabbits)

SCORING SYSTEM: Same scale as the one provided in the OECD guideline, with the exception of 1 criteria (changes related to discharge were included in addition to the other parameters evaluated)

TOOL USED TO ASSESS SCORE: slit lamp (The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, and 7 and was scored for each individual rabbit).

Calculation of the primary eye irritation:
The mean reaction scores for cornea, iris, and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively.

Index:
0 - 10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 84 = marked
above 84 = extreme

The ratio R = A : B indicates the effect of rinsing the eyes approximately 30 seconds after instillation of the compound.
< 1 = rinsing increased the effect of the compound
1 = no effect
1.1 – 1.5 = practically no effect
1.6 – 2 = littler but assessable effect
2.1 – 4 = good effect
4.1 – 10 = very good effect
> 10 = action of the compound practically abolished

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(for both rinsed and unrinsed eyes)
Basis:
mean
Time point:
other: 1, 2, 3, 4, and 7 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
(for both rinsed and unrinsed eyes)
Basis:
mean
Time point:
other: 1, 2, 3, 4, and 7 days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(for both rinsed and unrinsed eyes)
Basis:
mean
Time point:
other: 1, 2, 3, 4, and 7 days
Score:
0
Max. score:
0
Remarks on result:
other: Conjunctivae score includes observations on redness, chemosis, and discharge
Irritant / corrosive response data:
The substance was found to cause no irritation when applied to the rabbit eye mucosa. The primary irritation index for unrinsed and rinsed eyes was 0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU