Registration Dossier

Diss Factsheets

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
438-530-3
EC Name:
-
Cas Number:
5343-44-2
Molecular formula:
C20H41NO
IUPAC Name:
N,N-di-tert-butyldodecanamide
Details on test material:
- Name of test material (as cited in study report): N,N-dibutyldodecanamide (HAEL no. 94-0003, KAN 905762, CIN 10005762)
- Physical state: light yellow liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 1093-002
- Expiration date of the lot/batch: not reported

Test animals / tissue source

Species:
rabbit
Strain:
other: Hra:(NZW)SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Denver, PA, USA
- Age at study initiation: young adults
- Weight at study initiation: not reported
- Housing: individually in suspended, stainless steel mesh cages
- Diet (e.g. ad libitum): Agway Prolab High Fiber Rabbit Diet certified pellets ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 64-67°F
- Humidity (%): 66-75%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 25 April 1994 To: 29 April 1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 (3 washed, 3 non-washed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes. The eyes of 3 rabbits immediately washed with running distilled water
- Time after start of exposure: immedaitely after instillation

SCORING SYSTEM: according to OECD guideline 405 (Annex V Test B5)

TOOL USED TO ASSESS SCORE: fluorescein (pre-dose and 24 hour reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cornea, iris and chemosis scores - unwashed eyes
Basis:
other: animals 1, 2 and 3
Time point:
other: 24, 48, 72 hours
Irritation parameter:
other: conjunctival redness score - unwashed eyes
Basis:
other: animals 1 and 2
Irritation parameter:
other: conjunctival redness score - unwashed eyes
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: cornea, iris, chemosis and conjunctival redness scores - washed eyes
Basis:
other: animals 1, 2 and 3
Time point:
other: 24, 48, 72 hours
Irritant / corrosive response data:
Unwashed eyes: Slight conjunctival redness was present in all 3 rabbits at the 1 hour reading and persisted in one rabbit only until the 24 hour reading. No other signs of eye irritation were seen during the 72 hour observation period. Washed eyes: Slight conjunctival redness was seen in one rabbit at the one hour reading but did not persist. No other signs of eye irritation were seen during the 72 hour observation period.
Other effects:
None

Any other information on results incl. tables

Table: Eye irritation scores unwashed eyes - See attached report (page 10)

Table: Eye irritation scores washed eyes - See attached report (page 10)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
N,N-dibutyldodecanamide was non irritant to the rabbit eye (with or without subsequent irrigation).
Executive summary:

An eye irritation study was conducted in six rabbits. After administration of a single dose of 0.1 mL into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated.

N,N-dibutyldodecanamide was non irritant to the rabbit eye (with or without subsequent irrigation).