Registration Dossier

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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Salicylaldehyde
EC Number:
201-961-0
EC Name:
Salicylaldehyde
Cas Number:
90-02-8
Molecular formula:
C7H6O2
IUPAC Name:
salicylaldehyde
Details on test material:
- Name of test material(as cited in study report): 2-Hydroxybenzaldehyde - Physical state: colorless or pale yellowish clear oil liquid - Analytical purity: 99.9% - Stability under test conditions: stable

Test animals

Species:
rat
Strain:
other: Crj:CD(SD)IGS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS - Source: Charles River Japan, Inc. - Age at study initiation: 10 weeks old - Weight at study initiation: Female: 235-267 g - Housing: Three animals were housed in a stainless steel cage. - Diet: pellet chow, fasting after 17:00 of the previous day until 3 hrs after administration - Water: ad libitum - Acclimation period: 5 days ENVIRONMENTAL CONDITIONS - Temperature (℃): 22 ± 3℃ - Humidity (%): 55 ± 10 % - Ventilation (per hr): over 10 times/hr - Photoperiod (hrs light / hrs dark): 12 hrs light / 12 hrs dark 

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Administration by gavage was performed using a Teflon stomach tube. The animals were fasted after 17:00 until 3 hrs after administration. They had free access to water. The administration volume was 10 ml / kg b.w.
Doses:
Step 1: 300 mg/kg bw; Step 2: 300 mg/kg bw; Step 3: 2000 mg/kg bw
No. of animals per sex per dose:
3 per each step
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days - Frequency of observations:day 1 (day of administration): time just after administration ~ 1, 2, 4 and 6 hrs after administration day 2: once each at AM and PM after day 3: once at AM - Frequency of weighing: days 1 (before administration), 4, 8 and 15 - Necropsy of survivors performed: yes - Other examinations performed: Necropsy of dead animals 

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: approx. lethal dose
Effect level:
ca. 500 mg/kg bw
Based on:
test mat.
Mortality:
Step 1, 300 mg/kg: No mortality (0/3). Step 2, 300 mg/kg: No mortality (0/3) Step 3, 2000 mg/kg: All died (3/3).
Clinical signs:
Step 1, 300 mg/kg: No abnormality. Step 2, 300 mg/kg: Soft stool (1/3) Step 3, 2000 mg/kg: Death (3/3, within 24 hrs), Decreased locomotor activity (3/3), Deep respiration (1/3), Diarrhea (2/3), Soiled peritoneal region (2/2) 
Body weight:
300 mg/kg: increased steadily.
Gross pathology:
300 mg/kg: No abnormality. 2000 mg/kg (dead animals): No abnormality

Any other information on results incl. tables

GHS classification: Category 4

Table 1 Mortality of female rats treated with2-hydroxybenzaldehyde in the single dose oral toxicity test

Step

Dose(mg/kg)

Number ofanimalstreated

Number of animals that died

Mortality

Category(GHS)

LD50(mg/kg)

1

2

3

4

5

6

7

8 - 15 (days)

~ 0.5

~ 1

~ 2

~ 4

~ 6

~ 24 (hrs)

1

300

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0/3

4

500

2

300

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0/3

3

2000

3

0

0

1

0

1

1

0

0

0

0

0

0

0

3/3

Table 2 Clinical signs of female rats treated with 2-hydroxybenzaldehyde in the single dose oral toxicity test

Step

Dose(mg/kg)

Findings

1

2

3

4 -15(days)

Grade

~ 0.5

~ 1

~ 2

~ 4

~ 6(hrs)

1

300

Number of animals examined

 

3

3

3

3

3

3

3

3

Signs

0

0

0

0

0

0

0

0

2

300

Number of animals examined

 

3

3

3

3

3

3

3

3

Soft stool

0

0

1

0

0

0

0

0

3

2000

Number of animals examined

 

3

3

3

2

1

0

0

0

Decreased locomotor activity

1

1

1

2

1

0

2

0

1

1

0

0

Deep respiration

1

0

1

1

0

0

Diarrhea

1

0

2

1

0

0

Soiled perineal region

1

0

0

1

2

1

 

 

 

Grade, 1 : Slight; 2 : Moderate

Table 3 Body weight of female rats treated with 2-hydroxybenzaldehyde in the single dose oral toxicity test

Step

Dose(mg/kg)

Number ofanimals treated

Body weights (g)

1

4

8

15(days)

1

300

3

225 ± 6 (3)

256 ± 6 (3)

263 ± 10 (3)

266 ± 18 (3)

2

300

3

223 ± 8 (3)

254 ± 15 (3)

263 ± 15 (3)

276 ± 24 (3)

3

2000

3

225 ± 6 (3)

(0)

(0)

(0)

Values represent mean body weight ± S.D. (number of animals examined)

Table 4 Incidence of necropsy findings of female rats treated with 2-hydroxybenzaldehyde in the single dose oral toxicity test

Step

Dose(mg/kg)

Findings

Fate

Terminal kill

Found dead

1

300

Number of animals examined

3

0

No abnormalities detected

3

 

2

300

Number of animals examined

3

0

No abnormalities detected

3

 

3

2000

Number of animals examined

0

3

No abnormalities detected

 

3

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU