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Administrative data

Description of key information

The acute toxicity of Neononanoic acid glycidyl ester was accessed by an O.E.C.D. test guideline 425 UDP study.  The rat acute dermal toxicity of the structural analog 2,3-epoxypropyl neodecanoate  was evaluated by an O.E.C.D. test guideline 402 study.     

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 425 with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Female rats were acquired from Texas Animal Specialties; Humble, TX. and were Quarantined for 5 days before being placed on study. The animals weighted 172-222 gm on Day 0 (fasted). The animals were maintained in suspended stainless steel cages with wire bottom, I per cage. The temperature was 18-21°C and relative humidity was 29-95%. The animal room had 10-12 air changes/hour and a 12-hour light/dark cycle. PMI Feeds Inc.TM Formulab #5008 was available ad libitum except for approximately 16 hours before dosing. Municipal water supply analyzed by TCEQ Water Utilities Division was available ad libitum from automatic water system.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered as received and was not diluted. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 1.88 mL/kg. Each dose was administered using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after dosing.

Doses:
Approximately 2000 mg/Kg of body weight.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14, or at the time of discovery after death.

On Day 14 after dosing, each surviving animal was euthanized by an overdose of CO2. All study animals, whether dying during the study or euthanized, were subjected to gross necropsy and all abnormalities were recorded.
Statistics:
None required.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal
Clinical signs:
Clinical signs in one survivor included activity decrease, crusted muzzle, nasal discharge and piloerection, which were no longer evident by Day 3.
Body weight:
Animals surviving to study termination exhibited weekly normal weight gain during the study.
Gross pathology:
The gross necropsy on the animal that died on test revealed discolored lungs, liver and contents in the large intestine; and empty stomach and small intestine. The gross necropsy on animals surviving to study termination of the study revealed no observable abnormalities.
Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The rate acute oral LD50 of the test substance is > 2000 mg/kg of body weight.
Executive summary:

The acute oral toxicity of the test substance, Neononanoic acid glycidyl ester was accessed by an O.E.C.D. test guideline 425 UDP method. The rate acute oral LD50 of the test substance is > 2000 mg/kg of body weight under the conditions of the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The rat acute oral LD50 value was > 2000 mg/kg of body weight in an O.E.C.D. test guideline 425 UDP study with GLP compliance.

Acute toxicity: via inhalation route

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female rats of the CrI:CD.BR strain were obtained from Charles River (UK) Ltd, Margate. Animals were in a body weight range of 266 to 284 gm (males) and 232 to 248 gm (females) on Day -1. Based on information from the supplier the male rats were approximately six to eight and females, nine to ten weeks old on Day 1. The animals were housed up to five rats of the same sex in suspended stainless steel mesh cages.

The animal rooms were designed to permit at least 10 air changes per hour and to maintain environmental conditions of 19 to 25°C and 40 to 80% Relative humidity. SQC(E) Rat and Mouse Maintenance Diet No 1, from Special Diets Services Ltd, Witham was freely available to the animals at all times. Mains water was provided, ad libitum, via cage-mounted water bottles.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Electric clippers were used to remove all hair from an area of the dorsum measuring approximately 6 x 8 cm on the day before dosing. The dermal test site was an area approximately 5 x 5 cm (10% of the total body surface) on the clipped dorsum of the rat. The test article was spread as uniformly as possible across the dermal test site. A 5 x 5 cm dense gauze patch was placed over the treated skin and was retained in place by an elasticated, open-weave, adhesive bandage “Steroban” from Steroplast Ltd. Bredbury. This was wrapped securely around the torso of the animal to form a semi- occlusive dressing. The bandage and patch were removed 24 hours afier application. The test site of each rat was lightly brushed clean of any solid residues and swabbed with moist cotton wool before the animal was returned to it’s cage.

Duration of exposure:
24 hr
Doses:
2000 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Following exposure to the test substance treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded frequently on Day 1 and regularly for the remainder of the study, (the minimum schedule being at least once within half an hour of dosing and four times within the first four hours following administration, twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period). Individual records of clinical signs were maintained for each treated rat. Rats were weighed on Day -l and Days 1, 8 and 15.

The condition of each dermal test site was recorded following removal of the dressing on Day 2. The time schedule for observation was similar to that for clinical observations from Day 2.

At study termination the rats were killed by intraperitoneal injection of sodium pentobarbitone on Day 15. After exsanguination a full macroscopic necropsy was performed and all lesions recorded. The necropsy procedure included inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the dermal test site, liver and kidneys.



Statistics:
No data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Clinical signs of reaction to treatment included chromodacryorrhoea for two males and two females on Day 2; the same two females also had soiled anogenital regions on Day 2.
Body weight:
All rats placed on study gained weight normally during the first and second weeks of the study
Gross pathology:
Terminal examination revealed unilateral renal pelvic dilatation in one female and pale kidneys in a second female and pale areas on the spleen of one male (Table 6).
Other findings:
Dermal reactions were limited to observation of slight erythema on Day 2 and 3 with isolated cases of well defined erythema apparent shortly after removal of the semi- occlusive dressing. All reactions had resolved by Day 4.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance had an acute rat dermal LD50 of > 2000 mg/kg/day with little evidence of dermal irritation at the test sites.
Executive summary:

The structural analog test substance, 2,3-epoxypropyl neodecanoate was accessed for acute dermal toxicity to the rat by an O.E.C.D. test guideline 402 study. The test substance had an acute rat dermal LD50 of > 2000 mg/kg/day with little evidence of dermal irritation at the test sites. It is anticipated that Neononanoic acid glycidyl ester will behave in a similar manner.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The rat acute dermal LD50 value was > 2000 mg/kg of body weight in an O.E.C.D. test guideline 402 study with GLP compliance.

Additional information

The test substance, Neonoanoic acid glycidyl ester was found to have a acute rat oral LD50 value of > 2000 mg/kg of body weight. The structural analog, 2,3 -epoxypropyl neodecanoate has an acute rat dermal LD50 value of > 2000 mg/kg of body weight. Therefore, Neonoanoic acid glucidyl ester is generally non-tocic by the oral and dermal routes of exposure.

Justification for selection of acute toxicity – oral endpoint
As per REACH Annex VIII.

Justification for selection of acute toxicity – dermal endpoint
As per REACH Annex VIII.

Justification for classification or non-classification

Based on acute oral and dermal LD50 values of > 2000 mg/kg of body weight, Classification and Labeling is not required for these endpoints.