Nicotine sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

other: Secondary Literature

Title:

FAO EVALUATION FOR THE TEST CHEMICAL

Author:

FAO

Year:

2013

Bibliographic source:

FAO Evaluation, 2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 405 and EPA OPPTS 870.2400.

Principles of method if other than guideline:

To evaluate the eye irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-040-8

EC Name:

-

Cas Number:

imidacloprid (ISO)

Molecular formula:

C9H10ClN5O2

IUPAC Name:

imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine

Test material form:

solid

Details on test material:

Name of the test chemical: imidacloprid (ISO)
IUPAC Name: 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine
Molecular formula: C9H10ClN5O2
Molecular Weight: 255. g/mol
Substance Type: Organic
Physical State: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Sex: female

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.08 g of ground test substance

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

not specified

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3 female rabbits

Details on study design:

No additional details mentioned

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: no details mentioned

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.

Any other information on results incl. tables

Results of the acute toxicological studies:

Guideline	Number of animals	Dose	Method	Observations and results
OECD 405 and EPA OPPTS 870.2400	3 female rabbits	0.08 g of ground test substance.	Single instillation via the ocular route.	test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.

Executive summary:

An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits.The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation.In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.