Registration Dossier

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: Study conducted according to OECD guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness

Test animals / tissue source

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S
- Weight: 2.4-2.6kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Observation period (in vivo):
1h, 24h, 48h, 72h, 7d, 14d, 21d
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
corne opacity
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 21 days in 2 of 3 animals
Remarks on result:
other: When Fluorescein has been applied only the highest score for degree of corneal opacity from three readings are included
Irritation parameter:
iris score
Remarks:
iris lesion
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 0
Max. score:
2
Remarks on result:
other: normal reaction observed
Irritation parameter:
conjunctivae score
Remarks:
redness of conjunctiva
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 2.6
Max. score:
3
Reversibility:
fully reversible within: 21 days in 2 of 3 animals
Irritation parameter:
chemosis score
Remarks:
oedema of conjunctiva (chemosis)
Basis:
mean
Remarks:
three animals
Time point:
other: mean from 24h, 48h and 72h reading
Score:
<= 2.8
Max. score:
4
Reversibility:
fully reversible within: 21 days in 2 of 3 animals

Applicant's summary and conclusion

Interpretation of results:
other: Category 2
Remarks:
Criteria used for interpretation of results: other: EU GHS EC 1272/2008
Conclusions:
Eye irritant potential
Executive summary:

The eye irritant effect of SAT 970 419 (N,N-Dimethyldecan-1-amide) was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", 29.12.1992.

Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14 and in two animals 21 days after dosing.

Moderate to severe signs of eye irritation were observed among the rabbits.

The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:

Cornea opacity 1.0

Iris lesion 0.0

Redness of conjunctiva 2.6

Oedema of conjunctiva 2.8

After 14 days all animals showed hairless areas around the eye. Treatment related adverse eye reactions were fully reverse within 14 (1 animal) and 21 days.

Based on the result of this study the test substance is classified as eye irritant