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

Acute Toxicity: dermal

Administrative data

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.

Data source

Reference

Reference Type:

other: "Information from migrated NONS file, as per inquiry number 06-0000014943-66-0000, permission to refer granted by ECHA

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Annex V

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

412-260-6

EC Name:

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

Cas Number:

52658-19-2

Molecular formula:

C21H34N2O8 (molecular formula of the two isomers constituting the substance)

IUPAC Name:

2-({[(2R)-2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(2S)-2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(3R)-3,5,5-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(3S)-3,5,5-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[2,2,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate

Details on test material:

- Substance type: Very viscous clear yellowish liquid
- Physical state: liquid
- Analytical purity: >=95%

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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).