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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-08-01 to 1975-10-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Huntingdon study, conducted in 1975, non GLP, report without many details, therefore considered as reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
study conducted in 1975
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): toluene-2,5-diamine- Other: no further details given

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: no data- Age at study initiation: no data- Weight at study initiation: 98 - 120 g- Fasting period before study: starved overnight before treatment- Housing: grouping of 5 animals per sex per dose- Diet (e.g. ad libitum): no data- Water (e.g. ad libitum): no data- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data - Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aquous solution of sodium sulphite (0.05%)
Details on oral exposure:
VEHICLE- Concentration in vehicle: 10% solution- Amount of vehicle (if gavage): 2.5 mL- Justification for choice of vehicle: no justification given- Lot/batch no. (if required): no data- Purity: no dataMAXIMUM DOSE VOLUME APPLIED: 2.5 mL
Doses:
0, 64, 100, 160, and 250 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: According to the original study report, "during the observation period of 14 days, a record was kept on all mortalities and signs of toxicity".- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight (gain)
Statistics:
95% confidence limits were calculated by the method of Weil C.S. (1952)

Results and discussion

Preliminary study:
The results of preliminary range finding tests indicated that the median lethal oral dose (LD50) was in the region of 64 to 250 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
102 mg/kg bw
Based on:
test mat.
95% CL:
69 - 152
Mortality:
Males:0 mg/kg bw: 0 deaths / 5 test animals64 mg/kg bw: 3/5100 mg/kg bw: 4/5160 mg/kg bw: 0/5250 mg/kg bw: 5/5Females:0 mg/kg bw: 0 deaths / 5 test animals64 mg/kg bw: 0/5100 mg/kg bw: 3/5160 mg/kg bw: 5/5250 mg/kg bw: 4/5Deaths occured from 1 hour to 22 hours of treatment.
Clinical signs:
Lethargy, pilo erection, apraxia and increased salivation. Increase respiratory rate in rats treated at 100 mg/kg bw, and decreased respiratory rate in rats treated above 100 mg/kg bw.
Body weight:
Slightly depressed body weight gains were observed during the first week of treatment in femals rats treated at 64 and 100 mg/kg bw, and all surviving male rats. Body weight gains returned normal during the second week of observation, compared with controls.
Gross pathology:
Autopsy of dead animals revealed slight haemorrhage of lungs, pallor of the spleen, darkening of the liver, and injection of peritoneal blood vessels. for survivors after recovery, the terminal autopsy findings were normal.
Other findings:
none reported

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated informationCriteria used for interpretation of results: OECD GHS
Conclusions:
With a LD50 = 102 mg/kg bw, test item toluene-2,5-diamine shall be classified as oral acute toxic category 3, (toxic if swallowed, H301) according to the GHS/CLP classification system.
Executive summary:

The purpose of this study was to evaluate the acute oral toxicity of test item toluene-2,5 -diamine. The study was conducted in 1975 under non GLP conditions, without many details on the methodology given in the study report. Still the procedure as described in the study report obviously was similar to the protocol as given by OECD Guideline 401, thus the study is considered as reliable.

With a LD50 = 102 mg/kg bw, test item toluene-2,5-diamine shall be classified as oral acute toxic category 3, (toxic if swallowed, H301) according to the GHS/CLP classification system. Within the former DSD classification system the classification as T; R25 (toxic if swallowed) applies. Both classifications are in line with the harmonised classification already given for the test item (Annex VI of CLP regulation, Index # 612 -125 -00 -3).