L-(+)-2,5-diaminopentanoic acid

Endpoint summary

Description of key information

The substance does not meet the criteria for classification as to acute 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:

key study

Study period:

2006-05-09 to 2006-05-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

Non-GLP study

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot 05019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable

Species:

rat

Strain:

other: Crl: CD (SD)

Sex:

female

Details on test animals or test system and environmental conditions:

Age at time of dosing: 7 weeks

Route of administration:

oral: drinking water

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
0.5 % methylcellulose

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: 10 min, 30 min, 1 h, 2 h, 4 h, then daily
Weighing: Before dosing, after 1 d, 3 d, 7 d, 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (total fraction)

Mortality:

No mortality occured.

Clinical signs:

other: No symptoms developed throughout the study period.

Gross pathology:

Necropsy findings: No changes attributable to the test item were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is practically nontoxic when administered orally.

Executive summary:

L-(+)-2,5-diaminopentanoic acid was administered in a dose of 2000 mg/kg b.w. to female rats. No mortality occured. On other treatement related observations werde made.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch 1

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 exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Regarding inhalation, the combination of low volatility, a negative Log Kow and high water solubility suggests that absorption directly across the respiratory tract epithelium is unlikely.

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 physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Dermal absorption is unlikely because of the poor lipophilicity of L-(+)-2,5-diaminopentanoic acid. It suggests that the substance is not likely to cross the stratum corneum. Moreover, the low volatility in combination with the high water solubility and the negative Log P value indicate that the substance may be too hydrophilic to cross the lipid rich stratum corneum and thus dermal uptake will be unlikely.

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

L-(+)-2,5-diaminopentanoic acid was administered in a dose of 2000 mg/kg b.w. to female rats. No mortality occured. No other treatement related observations werde made.