A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate

Endpoint summary

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:

From December 01, 1993 to December 15, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd. Bicester, Oxon, England
- Strain: Hsd/Ola: Sprague-Dawley (CD)
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 100 - 117 g
- Fasting period before study: overnight prior to and 4 hours after dosing
- Housing: in groups of up to 5 rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 50
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 /12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSAGE PREPARATION (if unusual): not applicable

Doses:

2.0 g/ kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was checked at least twice daily. Clinical signs were recorded daily. Body weight recorded on day 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examinations

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths following a single oral dose of the test substance at 2.0 g/kg b.w.

Clinical signs:

other: Piloerection and increased salivation were observed in all rats within five minutes of dosing. Piloerection persisted until day 2 and was accompanied at later intervals on day 1 by abnormal body carriage (hunched posture) and soft or liquid faeces. Recove

Gross pathology:

No macroscopic abnormalities were observed for animals killed on day 15.

Interpretation of results:

not classified

Remarks:

M

Conclusions:

Under the study conditions, the acute lethal oral dose to rats of the test substance was found to be greater than 2000 mg/kg bw/d.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance to rat according to EU Method B.1. A group of ten fasted rats (five males and five females) was administered a single dose of the test substance, as supplied, at a dose level of 2000 mg/kg bw by gavage. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There was no mortality. Clinical signs of reaction to treatment included piloerection, abnormal body carriage (hunched posture), soft or liquid faeces and increased salivation in all rats. Recovery as judged by external appearance and behaviour, was complete by Day 3. No abnormalities were recorded at the macroscopic examination on Day 15. Under the study conditions, the acute oral LD50 of the test substance was found to be greater than 2000 mg/kg bw in rats (Parcell, 1993).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data provided by ECHA on request of Cytec Surface Specialties NV/SA. SNIF last update on 1993-10-25, UUID: SNIF-9afcc480-fb63-3500-a144-c5b56bbd2ec7.

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Annex V

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

other: Hoe: WISKf (SPF 71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not stated
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Fasting period before study: not stated
- Housing: not stated
- Diet (e.g. ad libitum): not stated
- Water (e.g. ad libitum): not stated
- Acclimation period: not stated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

Type of coverage:

occlusive

Vehicle:

other: sezam oil

Details on dermal exposure:

TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: not stated

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
- Time after start of exposure: not stated

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg b.w.
- Concentration (if solution): not stated
- Constant volume or concentration used: not stated
- For solids, paste formed: not stated

VEHICLE
- Amount(s) applied (volume or weight with unit): not stated
- Concentration (if solution): not stated
- Lot/batch no. (if required): not stated
- Purity: not stated

TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: not stated

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
- Time after start of exposure: not stated

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not stated
- Concentration (if solution): not stated

VEHICLE
- Amount(s) applied (volume or weight with unit): not stated
- Concentration (if solution): not stated
- Lot/batch no. (if required): not stated
- Purity: not stated

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Statistics:

No data

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg b.w. Number of animals: 5; number of deaths: 0
Female: 2000 mg/kg b.w. Number of animals: 5; number of deaths: 0

Clinical signs:

other: No signs of toxicity related to dose levels. No signs of systemic toxicity were observed.

Gross pathology:

Effects on organs:
No macroscopic abnormalities were observed.

Other findings:

Signs of toxicity (local):
Slight of well defined erythema was observed in all animals from day 2 onwards. This was accompanied in most by scaling, encrustations, indurations of a dry, rough surface. By day 7 on the males and day 13 in the females all skin sites were normal.

Interpretation of results:

not classified

Conclusions:

Under the study conditions, the single dose acute dermal LD50 of the test substance is greater than 2000 mg/kg bw/d in male and female rats.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance to rat according to EU Method B.3. A single dose of the test substance at 2000 mg kg/bw was applied to the skin of ten healthy rats for 24 h. The animals were observed for mortality, body weights, signs of gross toxicity, and behavioral changes for 14 d. Slight to well-defined erythema was observed in all animals from Day 2 onwards. This was accompanied in most by scaling, encrustations, indurations of a dry, rough surface. By Day 7 in the males and Day 13 in the females, all skin sites were normal. Under the study conditions, the acute dermal LD50 of the test substance was greater than 2000 mg/kg bw in rats (Anonymous, 1993).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute toxicity, oral:

A study was conducted to determine the acute oral toxicity of the test substance to rat according to EU Method B.1. A group of ten fasted rats (five males and five females) was administered a single dose of the test substance, as supplied, at a dose level of 2000 mg/kg bw by gavage. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There was no mortality. Clinical signs of reaction to treatment included piloerection, abnormal body carriage (hunched posture), soft or liquid faeces and increased salivation in all rats. Recovery as judged by external appearance and behaviour, was complete by Day 3. No abnormalities were recorded at the macroscopic examination on Day 15. Under the study conditions, the acute oral LD50 of the test substance was found to be greater than 2000 mg/kg bw in rats (Parcell, 1993).

Acute toxicity, dermal:

A study was conducted to determine the acute dermal toxicity of the test substance to rat according to EU Method B.3. A single dose of the test substance at 2000 mg kg/bw was applied to the skin of ten healthy rats for 24 h. The animals were observed for mortality, body weights, signs of gross toxicity and behavioral changes for 14 d. Slight to well-defined erythema was observed in all animals from Day 2 onwards. This was accompanied in most by scaling, encrustations, indurations of a dry, rough surface. By Day 7 in the males and Day 13 in the females, all skin sites were normal. Under the study conditions, the acute dermal LD50 of the test substance was greater than 2000 mg/kg bw in rats (Anonymous, 1993).

Justification for classification or non-classification

Based on the results of the acute oral and dermal toxicity studies, the substance does not warrant classification for acute toxicity according to EU CLP (1272/2008/EC) criteria.