Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity

NECTARYL was tested to evaluate the acute toxicity following a single oral administration (limit test) in rats according to the Guideline No. 401 in 1989.

From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.

Acute Dermal Toxicity

NECTARYL was tested to evaluate the acute toxicity following a single dermal administration (limit test) in rats according to the Guideline No. 402 in 1989.

From the results obtained under the experimental conditions employed, the LD0 by dermal route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 March 1989 to 11 september 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Substance name (as stated in the report): NECTARYL - LRG 1371
Description: colourless slightly viscous liquid
Batch: AS1241001
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain justifictaion: historically the rat has been used to determine acute toxicity of test substances and is chosen by the various regulatory authorities.
- Source: Iffa-Credo (69210 L'Arbresle - France)
- Age: young adults between 5 and 7 weeks old
- Weight at the start of treatment: from 145 g to 183 g (the individual weights for each sex varied by no more than 20 % of the mean weights of the animals)
- housing: Cages housed by sex and in groups of 5 (or 2 for the preliminary study), in type FI polycarbonate cages (interior dimensions 305 x 180 x 184 mm) for the preliminary study and in type MI (interior dimensions 365 x 225 x 180 mm) for the main study
- Air changes: at least 10 per hour
- Temperature: 21 to 27°C
- Humidity: 44 to 79 % R.H
- Lighting artificial: 12 hours out of 24 (photoperiod = 7h30 - 19h30)
- Hygiene: bedding changed once a week; cages changed for each study
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
test substance as supplied
Details on oral exposure:
- The test substance was administered once only after about 17 hours of a water only regime, the animals receiving food 4 hours after the intubation.
- Volume administered: 2.07 ml/kg of test substance as supplied
Doses:
A single dose level of 2008 mg/kg
No. of animals per sex per dose:
1 single dose to 5 males and to 5 females
Control animals:
no
Details on study design:
Since the absence of mortality was confirmed after the 14 day period, no other dose level was administered and the study was completed.
Preliminary study:
No deaths were seen at the dose level of 2008 mg/kg during the preliminary study.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 008 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 008 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
No mortality observed at highest dose tested
Mortality:
There were no deaths in any of the treated animals during the observation period.
Clinical signs:
There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.
Body weight:
Body weight changes in the treated animals were not influenced by treatment
Other findings:
There were no macroscopic findings that could be associated with treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
There were no effect of treatment in any of the parameters examined.
From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.
Executive summary:

NECTARYL was tested to evaluate the acute toxicity following a single oral administration (limit test) in rats according to the Guideline No. 401.

The test substance was administered, once only, as supplied and at the dose level of 2008 mg/kg, by the oral route (gastric gavage),in the Sprague-Dawley rat (5 males + 5 females).

Mortality and abnormal clinical signs were noted 15 minutes after intubation, and 1, 2 and 4 hours,and then daily for the 14day study period.

All animals were weighed the day before treatment (Day-1), immediately before administration of the test substance (Day1), on Days 8 and 15.

A necropsy was performed for all the animals after the 14day study period and the final observation (Day15).

There were no effect of treatment in any of the parameters examined.

From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 008 mg/kg bw
Quality of whole database:
OECD and GLP study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 March 1989 to 11 September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name (as stated in the report) : NECTARYL - LRG 1371
Identification for the study: 07683 D9 001
Description: colourless slightly viscous liquid
Batch No.: AS1241001
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source supplier: Iffa-Credo (69210 L'Arbresle - France)
- Age: young adults between 6 and 8 weeks old
- Weight at the start of treatment: from 209 g to 267 g (the weights for each sex varied by no more than 20 % of the mean the animals)
- Cages: housed individually in type FI polycarbonate cages (interior dimensions 305 x 180 x 184 mm)
- Air changes: at least 10 per hour
- Temperature: 21 to 27°c
- Humidity: 44 to 79 % R.H
- Lighting artificial, 12 hours out of 24 (photoperiod = 7h30 - 19h30)
- Hygiene: bedding changed once a week; cages changed for each study


Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
test substance as supplied
Details on dermal exposure:
The test substance was spread over an area of approximately 10 % of the total body surface area. It was applied uniformly using a finger covered by a very fine natural latex glove and to ensure penetration of all the substance or of the maximum possible quantity the area was lightly massaged for approximately 15 seconds.
The test substance was kept in contact with the skin by means a semi­ occlusive dressing composed of a perforated adhesive band (Peloplast) 10 cm wide, applied onto an elastic crepe bandage (Creplux / Molinier) covering the entire shaved area to avoid any possible orthoergic reactions and encircling the trunk of the animal without interfering with the abdominal and respiratory movements of the animal. This dressing entirely covered the treated area to avoid ingestion of the test substance by the animals.
Duration of exposure:
24 hour period
Doses:
2008 mg/kg
No. of animals per sex per dose:
A single dose was applied to a group of rats composed of 5 males and 5 females.
Control animals:
no
Details on study design:
Reason for the choice of the dose level : no deaths were seen at a dose level of 2008 mg/kg during the preliminary study.
Since the absence of mortality was confirmed after the 14 day observation period, no other dose level was applied and the study was considered completed.

Preliminary study:
No deaths were seen at a dose level of 2008 mg/kg during the preliminary study.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 008 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 008 mg/kg bw
Based on:
test mat.
Remarks:
No mortality observed at highest dose tested
Mortality:
There were no deaths in any of the treated animals during the observation period.
Clinical signs:
There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.
Body weight:
Body weight changes in the treated animals were not influenced by treatment.
Other findings:
There were no macroscopic findings that could be associated with treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
There were no effect of treatment in any of the parameters examined.
From the results obtained under the experimental conditions employed, the LD0 by cutaneous route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg.
Executive summary:

NECTARYL was tested to evaluate the acute toxicity following a single dermal administration (limit test) in rats according to the Guideline No. 402.

An acute toxicity study was conducted using rats. Ten animals were treated with a one-time application of Nectaryl, applied semi-occluded to the skin, at a dose of 2008 mg/kg. Clinical evaluations were performed 15 minutes after application, at 1, 2, and 4 hours, then daily for 14 days. There were no treatment related deaths during the study. A necropsy was performed on all animals after the 14 day study period. There were no clinical pathological signs noted. The study concluded that the cutaneous LD0 for Nectaryl in rats was equal to or greater than 2008 mg/kg.

LD50 dermal > 2008mg/kg, no mortalities or pathological clinical signs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 008 mg/kg bw
Quality of whole database:
OECD and GLP study

Additional information

Oral

An acute toxicity study (OECD 401, GLP) was conducted using rats. Ten animals were treated with a one-time application of Nectaryl, administered by gavage, at a dose of 2008 mg/kg. Clinical evaluations were performed 15 minutes after administration, at 1, 2, and 4 hours, then daily for 14 days. There were no treatment related deaths during the study. A necropsy was performed on all animals after the 14 day study period. There were no clinical pathological signs noted. The study concluded that the oral LD0 for Nectaryl in rats was equal to or greater than 2008 mg/kg.

LD50 dermal > 2008mg/kg, no mortalities or pathological clinical signs.

Dermal

An acute toxicity study (OECD 402, GLP) was conducted using rats. Ten animals were treated with a one-time application of Nectaryl, applied semi-occluded to the skin, at a dose of 2008 mg/kg. Clinical evaluations were performed 15 minutes after application, at 1, 2, and 4 hours, then daily for 14 days. There were no treatment related deaths during the study. A necropsy was performed on all animals after the 14 day study period. There were no clinical pathological signs noted. The study concluded that the cutaneous LD0 for Nectaryl in rats was equal to or greater than 2008 mg/kg.

LD50 dermal > 2008mg/kg, no mortalities or pathological clinical signs.

Inhalation

There is no study available on the test item

Justification for classification or non-classification

Based on the data available and key results described in this summary, the substance has shown no acute toxicity potential and should therefore not be classified for Acute oral and dermal toxicity according to the (EC) No 1272/2008 Regulation (CLP).