Reaction product of alkylarylsulphonic acid and cycloaliphatic amine

Endpoint summary

Description of key information

A formulation of the substance was tested in an acute oral test (limit test at 5000 mL/kg). One of ten animals died. The outcome was an LD50 of >5000 mL/kg, when corrected for purity 2150 mg/kg bw.

For inhalation toxicity an invalid study on a formulation of the substance was available. As the inhalation route is considered not very relevant for exposure this study is not further taken into account.

Dermal toxicity was evaluated for AMP (LD50 >2000 mg/kg bw), but not for PTSA in view of the corrosive effects of this acid. As the substance is a salt of PTSA corrosion is not expected. In view of the outcome of the acute oral toxicity study on the formulation of the study, it is expected that the substance is of low demal toxicity.

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:

weight of evidence

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

Acute Toxicity. FHSLA, CFR Title 21, para. 191.1.

Deviations:

yes

Remarks:

no information on body weight gain, no macroscopic examination

Principles of method if other than guideline:

no information on body weight gain, no macroscopic examination

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Weight at study initiation: 200-208 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS; no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 mL/kg bw

No. of animals per sex per dose:

10 males

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily for mortality and gross toxicity
- Necropsy of survivors performed: no

Statistics:

NA

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 150 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: corrected for purity based on a density of the formulation of 1 mg/cm3

Mortality:

none

Clinical signs:

none observed

Body weight:

no data

Gross pathology:

no data

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the substance is > 2150 mg/kg bw

Executive summary:

The substance (formulation) was tested for acute toxicity in 10 male rats at 5 mL/kg bw. No mortality or signs of toxicity were observed during the 14 -day observation period. The LD50 is >2150 mg/kg bw when corrected for purity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 150 mg/kg bw

Quality of whole database:

the test was perofmed on a formulation and the LD50 was claculated based on the concentration of the substance in the formulation

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:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards, well-documented, and acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Pharmacology Lab Protocol

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

12 Rabbits weighing 3.0 ± 0.5 kg (6 male, 6 female)8 Rabbits weighing 2.5 ± 0.5 kg (4 male, 4 female)

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

1st part of study:12 Rabbits were divided into 3 groups of 4 each (2 male and 2 female per group), and their abdomens were shaved free of hair. The skin of 2 rabbits per group (1 male and 1 female) were further prepared by abrasions. The abrasions were made 2-3 cm apart over the area of exposure with a blunt hypodermic needle without bleeding.Each group of rabbits was treated with either 1000, 1500, or 2000 mg of test material per kg body weight (mg/kg). The desired dose was spread over the prepared abdominal skin area (abraded or smooth as designated). The skin was covered with a gauze and a sheet of impervious rubberized cloth to prevent any loss of the test material. The trunk was further enclosed with a flexible wire screen held in place by tape. The animals were returned to individual cages.After 24 hours of dermal exposure, the bindings and patches were removed and the exposed areas gently cleaned and checked for irritation.2nd part.Upon completion of the 1st part of the study an additional 8 animals (4 male and 4 femal) were prepared in the same way as above, with the exception that all 8 animals were given abraded skin. These animals were then exposed to 2000 mg/kg bw using the same occluded dressings described above. After 24 hours exposure these animals had their dressings removed and the exposed area washed gently and examined for signs of irritation. These animals were also observed for a further 14 days.

Duration of exposure:

24 hours

Doses:

1000, 1500, or 2000 mg of test material per kg body weight (mg/kg) (doses calculated for each animal based on individual bodyweight)

No. of animals per sex per dose:

4 rabbits/dose, then an additional 8 animals at 2000 mg/kg

Control animals:

no

Details on study design:

Rabbits were weighed at the start of the study and at the end of the 14 day observation period.All animals were sacrificed at the end of the study and necropsied to assess gross pathology. There was no Hematology, clinical chemistry or histopathology carried out on any of the animals.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

At the end of the 24 hour exposure period, the intact and abraded treated skin sites were severely irritated and black in color. The sites became necrotic within two to three days and remained necrotic for the 14 days. The treated sites had severe eschar formation by the 14th day. The animals in all treated groups showed no signs of toxicity or abnormal pharmacological behavior.

Body weight:

The rabbits in the three treatment groups lost body weight over the 14 day observation period.

Gross pathology:

At necropsy, all organs in all rabbits were grossly normal. The treated skin sites in all rabbits were necrotic.

Other findings:

Not applicable

Not applicable

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for P-1826 for the rabbit was >2000 mg/kg. The test material was dermally nontoxic, but was a severe skin irritant.

Executive summary:

P-1826 (AMP, 2-amino-2-methyl-l-proano1) was tested for acute dermal toxicity using 12 rabbits. The Rabbits were split into 3 groups of 4. All rabbits had their abdomens shaved free of hair, 2 animals in each group also had their skin abraded using a blunt hypodermic needle. The test material was applied at doses of 1000, 1500 or 2000 mg/kg bw under an occluded dressing for 24 hours. After the exposure period the rabbits were observed for a further 14 days. Following this first test an additional 8 rabbits were used. The abdomen of each rabbit was shaved and then abraded using a blunt hypodermic needle. These rabbits were exposed for 24 hours to 2000 mg/kg bw AMP and then followed for a further 14 days. A t the end of 24 hr exposure, the intact andabraded treated skin sites were severely irritated and black in color. The sites became necrotic within two to three days and remained necrotic for the 1 4 days. The treated sites had severe eschar forrnation by the 14th day, The rabbits in the three treatment groups lost body weight over the two-week observation period. The animals in all the treated groups showed no signs of toxicity or abnormal pharmacological behavior. At necropsy the organs in all rabbits were grossly normal. The treated skin sites in all the rabbits were necrotic. In conclusion, AMP was dermally nontoxic (LD50 > 2000 mg/kg), but was a severe skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Based on the considerations above the substance is not to be classified for acute toxicity according to (EC) No 1272/2008 (CLP).