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Diss Factsheets

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17th December 1984 to 23rd January 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecyltrimethylammonium chloride
EC Number:
203-927-0
EC Name:
Dodecyltrimethylammonium chloride
Cas Number:
112-00-5
Molecular formula:
C15H34N.Cl
IUPAC Name:
N,N,N-trimethyldodecan-1-aminium chloride
impurity 1
Chemical structure
Reference substance name:
Trimethyl(tetradecyl)ammonium chloride
EC Number:
224-958-6
EC Name:
Trimethyl(tetradecyl)ammonium chloride
Cas Number:
4574-04-3
Molecular formula:
C17H38N.Cl
IUPAC Name:
N,N,N-trimethyltetradecan-1-aminium chloride
impurity 2
Chemical structure
Reference substance name:
Cetrimonium chloride
EC Number:
203-928-6
EC Name:
Cetrimonium chloride
Cas Number:
112-02-7
Molecular formula:
C19H42N.Cl
IUPAC Name:
N,N,N-trimethylhexadecan-1-aminium chloride
Test material form:
liquid
Specific details on test material used for the study:
CAS number: 112-00-5
Mol. Weight: 263.9

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Animal Species: Rabbit/ White VIENNA
Animal Breeder: Gaukler; D-6050 Offenbach / Main. FRG
Type of cage: Cage made of stainless steel with wire mesh walk floors, floor area: 40cm x 51cm
Number of animals per cage: 1
Animal identification: Ear Tattoo (=animal number)
Room Temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioned guaranteed a range of 20 - 24 degrees celsius for temperature and of 30 - 70% for relative humidity.
Day/night Rhythm: 12H/12H (6.00 - 18.00 hours / 18.00 - 6.00 hours)
Bedding: NO bedding in the cages: sawdust in the waste trays
Diet: KLIBA 341, 4MM. Firma Klingentalmuehle AG, Switzerland.
Drinking water: About 250mL tap water per animal per day.
Acclimatization period: At least 8 days before the beginning of the study: same housing conditions as during the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.1 mL (unchanged)
Duration of treatment / exposure:
Single application. The substance is not washed out
Observation period (in vivo):
Observation period: 9 days
Readings: 1 hours, 24 hours, 48 hours, 72 hours, 9 days after application
Number of animals or in vitro replicates:
Number of animals: 3 (1 male and 2 females)
Details on study design:
Number of animals: 3 (1 male and 2 females)
Mean weight (KG): 2.47 (male) and 2.75 (female)
Application volume: 0.1 mL (unchanged)
Observation period: 9 days
Readings: 1 hours, 24 hours, 48 hours, 72 hours, 9 days after application
Negative control: Untreated eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 9 d
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 9 d
Score:
1
Max. score:
2
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 9 d
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 9 d
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 9 d
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 9 d
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 9 d
Score:
1
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 9 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 9 d
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 9 d
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 9 d
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 9 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
MEAN:
Animal#1:
Cornea opacity score: 1.0
Iris score: 0.0
conjunctive score: 2.0
chemosis score: 2.3
Animals#2;
Cornea opacity score: 1.0
Iris score: 0.0
conjunctive score: 2.0
chemosis score: 2.3
Animals#3:
Cornea opacity score: 1.3
Iris score: 0.0
conjunctive score: 2.3
chemosis score: 2.3

MEAN animals#1,2 and 3:
Cornea opacity score: 1.1
Iris score: 0.0
conjunctive score: 2.1
chemosis score: 2.3

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Eye irritant Cat. 2
Executive summary:

Title: Report on the acute irritation to the eye of the white rabbit based on OECD (405)

Testing facility: BASF aktiengesellschaft

Aim of the study: Assessment of a possible irritating potential to the eye and to the eye mucosa.

Test substance: CAS N° 112 -00 -5

Conclusion: Eye irritant Cat. 2 (GHS classification)