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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2020/21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 433 (Acute Inhalation Toxicity: Fixed Concentration Procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,20:3,19-Dimethano-2,3,4a,5a,6a,7a,8a,9a,10a,11a, 12a,13a,14a,15a,16a,17a,19 ,20,21a,22a, 23a,24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-dotriacontaazabispentaleno [1''',6''':5'',6'',7''] cycloocta[1'',2'',3'':3'',4'']pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno [1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-1,4,6,8,10,12, 14,16,18,21,23,25,27,29,31,33-hexadecone, hexadecahydro-, stereoisomer,2,18:3,17-Dimethano-2,3, ,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a, 20a,21a,22a,23a,24a, 25a,26a,27a,28a,29a,30a-octacosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta [1'',2'',3'':3'',4''] pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene- 1,4,6,8,10,12,14,16,19,21,23,25,27,29-tetradecone, tetradecahydro-, stereoisomer, 1H,4H,12H,15H-2,14:3,13-Dimethano-5H,6H,7H,8H,9H,10H,11H,16H,17H,18H,19H,20H,21H,22H-2,3,4a, 5a,6a,7a,8a,9a,10a,11a,13,14,15a,16a,17a,18a,19a,20a,21a,22a-eicosaazabispentaleno [1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene- 1,4,6,8,10,12,15,17,19,21-decone, decahydro-, stereoisomer
EC Number:
946-188-6
Molecular formula:
(C6H6N4O2)n, n=6,7,8
IUPAC Name:
2,20:3,19-Dimethano-2,3,4a,5a,6a,7a,8a,9a,10a,11a, 12a,13a,14a,15a,16a,17a,19 ,20,21a,22a, 23a,24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-dotriacontaazabispentaleno [1''',6''':5'',6'',7''] cycloocta[1'',2'',3'':3'',4'']pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno [1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-1,4,6,8,10,12, 14,16,18,21,23,25,27,29,31,33-hexadecone, hexadecahydro-, stereoisomer,2,18:3,17-Dimethano-2,3, ,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a, 20a,21a,22a,23a,24a, 25a,26a,27a,28a,29a,30a-octacosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta [1'',2'',3'':3'',4''] pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene- 1,4,6,8,10,12,14,16,19,21,23,25,27,29-tetradecone, tetradecahydro-, stereoisomer, 1H,4H,12H,15H-2,14:3,13-Dimethano-5H,6H,7H,8H,9H,10H,11H,16H,17H,18H,19H,20H,21H,22H-2,3,4a, 5a,6a,7a,8a,9a,10a,11a,13,14,15a,16a,17a,18a,19a,20a,21a,22a-eicosaazabispentaleno [1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene- 1,4,6,8,10,12,15,17,19,21-decone, decahydro-, stereoisomer
Test material form:
solid
Details on test material:
purity >85 % (w/w)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
clean air
Mass median aerodynamic diameter (MMAD):
>= 2.7 - <= 2.8 µm
Geometric standard deviation (GSD):
>= 2.33 - <= 2.58
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
targeted: 5 mg/l, achieved: 5.35 mg/l
No. of animals per sex per dose:
1 male and 1 female for the sighting study, 5 male animals for the main study
Control animals:
no

Results and discussion

Preliminary study:
In 1 male and 1 female absence of mortality or toxicity at a target exposure level of 5 mg/L
Effect levels
Key result
Sex:
male
Dose descriptor:
LC0
Effect level:
5.35 mg/L air
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
salivation
Body weight:
On the day following exposure (Day 2), body weight loss was evident in 4/5 males exposed to 5.35 mg/L. The group mean body weight was comparable to Day 1 values by the next weighing occasion (Day 7) and continued to increase for the remainder of the observation period.
The changes in body weight gain on Day 2 are considered to be a consequence of the exposure (duration and removal of food and water), and therefore not test item-related.
Gross pathology:
The macroscopic examination after a single exposure followed by a fourteen day observation period for males exposed to 5.35 mg/L revealed no abnormalities.

Any other information on results incl. tables

Salivation was seen in 2/5 males on return to home cage, resolving by the end of the working day check.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 (4-hour) is in excess of 5.35 mg/L for male rats.
Executive summary:

There were no test item-related deaths, macropathology findings or effects on body weight in an acute nose-only inhalation study in rats in accordance with OECD guideline 433. Under the conditions of this study the LC50 (4-hour) is in excess of 5.35 mg/L for male rats.