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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
EC Number:
214-619-0
EC Name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
Cas Number:
1166-46-7
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 2
Chemical structure
Reference substance name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
EC Number:
257-144-4
EC Name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
Cas Number:
51348-90-4
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 3
Chemical structure
Reference substance name:
1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Cas Number:
1166-48-9
Molecular formula:
C19H25NO4
IUPAC Name:
1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 4
Chemical structure
Reference substance name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Cas Number:
51348-91-5
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Test material form:
solid: crystalline
Details on test material:
the racemate is characterized by CAS-number 7696-12-0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Standard laboratory conditions: air conditioned with adequate fresh air supply; environment: temperature 18 - 23 °C, relative humidity 30 - 70%, with a 12 hour light (natural light supplemented with artificial fluorescent light) and 12 hour dark cycle.
Housing
Housed individually in fibre board cages (size: L 77 x B 54 x H 63 cm) having provision for pelletted diet and drinking water. Bedding: Steam sterilized paddy husk changed twice a week.
Diet and water ad libitum.

Test system

Vehicle:
other: corn oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
53 mg (quantity equivalent to volume of 0.1 l)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
On the test day one, a quantity of 53 mg (quantity equivalent to volume of 0.1 l) of finely ground test item was instilled into the conjunctival sac of the left eye of each rabbit after gently pulling the lower eye lid away from the eye ball. The eye lids were then gently held together for about one second to prevent loss of the test item. A pre-weighed aluminium foil was held below the eye lid in order to capture the test item which was lost during instillation. The right eye remained untreated and served as the reference control.
The rabbits were restrained with Elizabethan collar for 24 hours post-instillation.
After 24 hours contact period the treated eyes were irrigated with deionised water to remove the residual test item. The control eye was also washed similarly. The eyes of each animal were examined at 1, 24, 48 and 72 hours after instillation and scored according to the procedure described in the guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
1.PRE-TERMINAL DEATHS
There were no pre-terminal deaths.
2.BODY WEIGHTS
Body weights of two rabbits (R84237 and RB4238) increased through the observation period whereas terminal body weight of one rabbit (RB4239) was same as that of the body weight at start of treatment.
3.TOXIC SIGNS
No toxic signs were observed.
4.NECROPSY
No abnormality was detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results indicate that the test item tetramethrin tech. grade is:
a) "non-irritant' to the eyes of New Zealand white rabbits based on the scores at 24 hours under the testing conditions adopted and
b) is classified into Category IV 'Minimal effects clearing in less than 24 hours' as per the classification of US EPA toxicity categories.
The test item tetramethrin tech. grade does not meet the criteria to be classified as "Irritating to eyes" of New Zealand white rabbits as specified under the EU labelling regulations according to Commission Directive 93/21/EEC.
Executive summary:

The test item tetramethrin tech. grade was tested for its eye irritation properties in New Zealand white rabbits.

A quantity of 53 mg (quantity equivalent to volume of 0.1 ml) of the test item was instilled into the conjunctival sac of the left eye. The right eye served as the reference control. The effects on the conjunctiva, cornea and iris were scored by Draize's Evaluation method at 1, 24, 48 and 72 hours post-instillation.

The results indicate that the test item tetramethrin tech. does not meet the criteria to be classified as "Irritating to eyes" of New Zealand white rabbits as specified under the EU labelling regulations according to Commission Directive 93/21/EEC.