Octamethylenediamine

Endpoint summary

Description of key information

Oral: The acute oral LD50 was investigated in 4 studies and was determined to be ca. 500 mg/kg bw in rats.
Dermal and inhalation toxicity: In accordance with column 2 of REACH Annex VIII, the test on acute toxicity (required in section 8.5) does not need to be conducted as the available information show  that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, no further testing is required in accordance with animal welfare reasons.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

500 mg/kg bw

Additional information

Oral toxicity:

1) The acute oral toxicity of Octamethylenediamine was investigated using the BASF Test (10A0081) which in principle follows the method described in OECD Guideline 423. 3 rats per sex and dose were treated simultaneously by gavage (single administration) with preparations of the test substance in water. The doses 200mg/kg and 2000mg/kg were tested. Group-wise documentation of clinical signs was performed over the 14 days study period. The clinical signs and findings were reported in summary form. Symptoms of intoxication were only observed at the dose level of 2000 mg/kg bw and included dyspnea, apathy, abnormal body positions, staggering, paresis, piloerection, exsiccosis and a general bad condition of the animals, starting partially already 30 min after application. All animals (male and female) died in the dose group of 2000 mg/kg bw within the first day after application. No animal died in the lower dose group. Animals died during the study (2000 mg/kg dose group) were examined as soon as possible and showed a general congestion. Additionally, a moderate emphysema (of the lungs), an intense red fore-/glandular stomach was observed with a thickened wall as well as the small intestine possessed a reddened mucosa and bloody contents. For sacrified animals (14 days after application) no pathological findings were noted. Due to these results, the oral toxicity is characterised by a LD50 range more than 200 mg/kg bw but less than 2000 mg/kg bw for both male and female rats together.

2) The acute oral toxicity of Octamethylenediamine was investigated using the BASF Test (XIII/214) which in principle follows the method described in OECD Guideline 423. 5 Hannover mice (male and female) per dose group were treated simultaneously with a single oral administration of 1600 and 200mg/Kg of the test substance diluted in aqua dest. (vehicle) by gavage while 5/5 animals of the high dose group and 0/5 of the low dose group died within one day. On the next day another group of mice were dosed with 800 and 400mg/kg. 3/5 of the animals dosed with 800mg/kg and 0/5 animals dosed with 400mg/kg died within 3 days. 4 days after the second group of animals were treated another group of mice were dosed with 500 and 640mg/kg. 1/5 of the 500mg/kg dose group died while dosage with 640mg/kg killed 3/5 animals. During the 7 days after the administration the clinical signs and symptoms were recorded at least once each day. After administration the animals showed calm behaviour, sunken flanks and accelerated respiration. From day 1 until day 6 the animals showed staggering, inactivity and piloerection. On the end of the observation time the mice were gross-pathologically examined. A necropsy of the animals died before the end of the study was performed as early as possible. The animals died during the study developed redness of lower stomach and parts of the intestine while the sacrified animals did not show any findings. Depending on the mortality of the treated animals an LD50 of ca. 600mg/kg was determined.

3) The acute oral toxicity of Octamethylenediamine was investigated using the BASF Test (XVII/116) which in principle follows the method described in OECD Guideline 423. 5 rats per sex and dose were treated simultaneously with a single oral administration of 1600, 200 and 25mg/Kg of the test substance diluted in aqua dest. (vehicle) by gavage while 8/10 animals of the high dose group and 0/10 of the low dose groups died within one day. 3 days later another group of rats were dosed with 800 and 400mg/kg. 10/10 animals dosed with 800mg/kg and 1/10 animals dosed with 400mg/kg died within 1 day. 1 day after the second group of animals were treated another group of rats were dosed with 500 and 640mg/kg. The dosage of 500mg/kg killed 4/10 animals while 8/10 rats died after administration of 640mg/kg. During the 7 days after the administration the clinical signs and symptoms were recorded at least once each day. Shortly after administration the rats showed dyspnoea and after 10 minutes apathy, abdominal position, closed eyes, bloody discharge from eyes and nose as well as exophthalmos. The animals dosed with 1600mg/kg showed lateral position and hemorrhagic urine 10 minutes after administration. After 1 day clinical signs were piloerection and bloody crusted eyes and noses. Animals treated with 1600mg/kg showed apathy, dyspnoea, bloody crusted eyes and noses and piloerection 3 days after administration of the test substance. All clinical findings of survivors were fully reversible after 5 days. On the end of the observation time the rats were gross-pathologically examined. A necropsy of the animals died before the end of the study was performed as early as possible. Died animals showed diarrhea (5x), steatosis (1x) and small subcapsular necroses (1x) while pale liver (2x), hyperinflation (1x) and mucous intestinal contents (4x) were observed in sacrified rats. Based on the mortality of the treated animals an LD50 of ca. 500mg/kg was determined.

4) 300, 450, 670, 1000 or 2300 mg/kg of a suspension of the test substance in corn oil was administered orally to one male rat per dose level. Surviving animals were observed through 14 days and clinical signs were reported. After the application of 1000 and 2300 mg/kg 1/1 animal died within 3 days. Animals dosed with up to 300 mg/kg did not develop any clinical signs. Animals dosed with 450 and 670 mg/kg showed initial weight loss, lethargy, lung noise, labored breathing, diarrhea as well as brown nasal and oral discharges. After the application of 1000 and 2300 mg/kg clinical signs were lethargy, lung noise and labored breathing. The LD50 of the test substance is higher than 670mg/kg and smaller than 1000mg/kg.

Justification for classification or non-classification

Octamethylenediamine is harmful after oral administration (EU: R22; GHS acute oral cat. 4, H302) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.