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Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 5000 mg/kg bw

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw

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:
15 - 29 May 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: KFM-Han Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 200 - 234 g (males), 167 - 182 g (females)
- Fasting period before study: 12 - 18 h
- Housing: in groups of 5 in Macrolon type 3 cages with standard softwood bedding
- Diet: pelleted standard Kliba 343, batch 98/84 rat maintenance diet (Klingentalmuehle AG, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 May 1984 To: 29 May 1984
Route of administration:
oral: gavage
Vehicle:
other: 2% CMC (carboxymethlcellulose) natriumsalt purum in distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION: the test substance and vehicle were added to a glass beaker and a weight by weight suspension was prepared using a homogenizer. The homogeneity of the suspension was maintained during treatment using a magnetic stirrer.
Doses:
5000 mg/kg bw
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: Animals were observed for mortality and morbidity, and clinical signs were noted 4 times on Day 1 (day of administration) and daily thereafter. The body weight was recorded on Day 1 (prior to administration), Day 8 and Day 15.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: 5/5 males and 5/5 females exhibited dyspnea on Day 1 until 5 h after dosing. Ruffled fur was observed in 5/5 males and 5/5 females 1 - 2 h after administration, and a curved body position was observed in 5/5 males and 5/5 females 1 - 3 h after dosing on D
Gross pathology:
The necropsy did not show substance-related findings.

Table 1. Acute oral toxicity

Dose

[mg/kg bw]

Mortality

Clinical signs

 

N*

N*

Males

5000

0/5

5/5

Females

5000

0/5

5/5

*N= Number of animals/ number of animals used

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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
Study period:
26 Jul - 10 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted in 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: WISTAR Crl: WI(Han)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6 - 8 weeks (males), 8 - 10 weeks (females)
- Weight at study initiation: 235 - 249 g (males), 212 - 222 g (females)
- Housing: individual in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water:tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with the skin using a gauze-dressing, non-irritating tape and an additional dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with aqua ad iniectabilia
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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: Animals were observed several times on the day of dosing and once daily therafter. Individual body weights were determined prior to the application on day 1 and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occured during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute toxicity: oral

The acute oral toxicity of Reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16- diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate (CAS 72869-86-4) was assessed in a study conducted according to OECD guideline 401 and under GLP conditions (Ullmann, 1984). Five (5) KFM-Han Wistar rats/sex were administered 5000 mg/kg bw test substance in 2% carboxymethylcellulose via gavage. There was no mortality during the 14-day study period. 5/5 males and 5/5 females exhibited dyspnea on Day 1 until 5 h after dosing. Ruffled fur was observed in 5/5 males and 5/5 females 1 - 2 h after administration, and a curved body position was observed in 5/5 males and 5/5 females 1 - 3 h after dosing on Day 1. The body weight gain was within the range that is normal for this strain and study type. No findings were reported during the macroscopic examination. The acute oral LD50 value is considered to be > 5000 mg/kg/bw.

Reaction mass of 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate and 7,9,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diylbismethacrylate  (CAS 72869-86-4) was assessed for its acute oral toxicity potential in a study that was performed using a protocol similar to OECD guideline 401 (Sterner, 1977). Ten SPF-Wistar rats/sex were administered 20 mL/kg bw undiluted test substance via gavage. The test substance was heated to 40°C prior to administration. The rats were observed repeatedly for mortality/morbidity and the clinical signs recorded on the day of exposure (Day 0), and once on Day 7 and 14. 1/10 males died on Day 7. The number of animals suffering clinical signs was not disclosed. Slightly reduced activity and general response was noted 1 - 24 h after test substance administration. Increased abnormal gait was reported from 1 - 3 h after administration and piloerection until 24 h after dosing. Diarrhoea was observed up to 7 days after test substance administration. The body weight of 1/10 females was reduced on Day 14. The body weight gain of the remaining 10/10 males and 9/10 females was within the expected range during the study period. In the male that died, redness of the mucous membrane in the stomach and intestine was observed. A hard residue of the test substance was observed in the stomach. None of the surviving rats showed any treatment-related effects during necropsy. The acute oral LD50 value is considered to be > 20 mL/kg bw (equivalent to 22.24 g/kg bw based on a density value of 1.112 g/mL).

Acute toxicity: dermal

The acute dermal toxicity of the test substance was assessed in a study conducted according to OECD guideline 402 and under GLP conditions (Holalagoudar, 2016). Five male and five female Wistar Crl: WI(Han) rats were treated with the test substance by a single semi-occlusive dermal application at 2000 mg/kg bw. The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. No mortality occurred and no clinical signs or signs of local irritation were observed. There were no treatment related effects on body weight or body weight gain. There was no evidence of any observations at a dose level of 2000 mg/kg bw at necropsy. Thus, under the conditions of this study, the acute dermal LD50value of the test substance was found to be > 2000 mg/kg bw in male and female Crl: WI(Han) rats.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.