2-(undec-10-enoylamino)-3-phenylpropanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

LCA02007

IUPAC Name:

LCA02007

Details on test material:

• Container : plastic tube
• Form : powder
• Quantity : 14.87g (Container + Content)
• Colour : white
• Batch : 157 LG
• Storage: room temperature
It was identified under the code number : PH-02/0110.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

6 Sprague Dawley rats (SPF Caw) originated from IFFA CREDO (69210 L’Arbresle – France), were
used after a 4 to 5-day acclimatisation period. At the beginning of the study, the animals weighted
between 181g and 194g (males) and between 156g and 166g (females).

Environmental parameters for the treated group:
- temperature : between 20°C and 24°C
- relative humidity : between 44% and 48%

Group 1 (control) : 3 male rats Rm1942 to Rm1944
and 3 female rats Rf1923 to Rf1925
Group 2 (treated) : 3 male rats Rm1948 to Rm1950
and 3 female rats Rf1929 to Rf1931

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

The animals of Group 2, received an effective dose of 2000 mg/kg body weight of product LCA02007, diluted with dimethyl sulfoxyde and administered by force-feeding under a volume of 9.5ml/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: >= 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: >= 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the product LCA02007 is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 93/21, the product LCA02007 must not be classified.

Executive summary:

The product LCA02007 was administered to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline n0 423 dated March 22nd, 1996 and the test method B.1ter of the E.E.C. Directive no 96/54 dated July 30th, 1996.

No mortality occurred during the study.

No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the product LCA02007 is higher than 2000 mg/kg body weight by oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 93/21, the product LCA02007 must not be classified.