Reaction products of 4,4'-methylenebis(cyclohexylamine) and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Endpoint summary

Description of key information

The test substance was tested accoring to OECD 423. The oral LD50 value in Wistar rats was established to be within the range of 500-2000 mgkg body weight (NOTOX 2000). Acute toxocty in a second route is not necessary because the test substance is corrosive to skin.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised
by international guidelines as the recommended test system (e.g.OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals 15 Animals. Each dose group consisted of 3 animals.of one sex
(females were nulliparous and non-pregnant).
Age and body weight Young adult animals (approx. 6-8 weeks old) were selected. Body
weight variation did not exceed +I- 20% of the sex mean.
Identification Earmark.
Conditions
A controlled environment was maintained in the room with optimal conditions considered as
being approximately 15 air changes per hour, a temperature of 21*3"C, a relative humidity of
30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
Temporary deviations from the maximum level for relative humidity (with a maximum of 20%)
and from the maximum level for temperature (with a maximum of 1 "C) did occur. Based on
laboratory historical data these deviations were considered not to have affected the study
integrity.
Accommodation
Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV) containing
purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of
analysis were examined and then retained in the NOTOX archives.
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF I), Lage,
Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in
the NOTOX archives.

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

Method Oral gavage, using a stainless steel stomach tube.
Fasting Food was withheld overnight (for a maximum of 20 hours) prior to
dosing until approximately 3-4 hours after administration of the test
substance.
Frequency Single dosage, on day 1

Doses:

Dose level (volume) 2000 mglkg (1 0 mllkg) body weight.
200 mglkg (10 mllkg) body weight.
500* mglkg (10 mllkg) body weight.

No. of animals per sex per dose:

3 animals, highest dose only 3 female animals

Control animals:

no

Details on study design:

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals.
The first group was treated at a dose level of 2000 mglkg body weight. The absence or
presence of mortality of animals dosed at one step determined the next step, based on the test
procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity
were to be taken into account for determination of the time interval between the dose groups.
OBSERVATIONS
MortalityNiability Twice daily. The time of death was recorded as precisely as
possible.
Body weights Days 1 (pre-administration), 8 and 15 and at death (if found dead
after day 1).
Clinical signs
Necropsy
At periodic intervals on the day of dosing (day 1) and once daily
thereafter, until day 15. The symptoms were graded according to
fixed scales and the time of onset, degree and duration were
recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
The moribund animals and animals surviving to the end of the
observation period were sacrificed by asphyxiation using a
oxygenlcarbon dioxide procedure. All animals assigned to the
study were subjected to necropsy and descriptions of all internal
macroscopic abnormalities recorded.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality was as follows, presented in chronological order of treatment:
Dose level Mortality Sex
2000 mgkg 3/3 females
200 mglkg 0/3 females
200 mglkg 0/3 males
500 mg/kg 1/3 females
500 mg/kg 0/3 males

The decedents were found on day 1,2 or 3 post-treatment.

Clinical signs:

other: Clinical signs observed during the study period were as follows: Dose level Clinical signs 2000 mgkg Lethargy, flat posture, slow breathing, moribund, ptosis, hunched posture, piloerection. 200 mglkg Lethargy, uncoordinated movements, hunched posture.

Gross pathology:

Macroscopic post mortem examination in the animals found dead revealed:
2000 mgkg: Abnormalities of the stomach (dark red discoloration of the glandula mucosa)
andlor duodenum and jejunum (dark red discoloration).
500 mglkg: No abnormalities.
Macroscopic examination of the surviving animals at termination did not reveal any
abnormalities.

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LDS0value of PACM BADGE ADDUCT in Wistar rats was established to be within the range of 500-2000 mgkg body weight.

Executive summary:

The oral LDS0value of PACM BADGE ADDUCT in Wistar rats was established to be within the range of 500-2000 mgkg body weight.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the acute oral toxicity study, the test substance has not to be classified  according to CLP regulation 1272/2008.