Salicylaldehyde

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: 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

Test material information

Constituent 1

Reference substance name:

Salicylaldehyde

EC Number:

201-961-0

EC Name:

Salicylaldehyde

Cas Number:

90-02-8

Molecular formula:

C7H6O2

IUPAC Name:

2-hydroxybenzaldehyde

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:

other: 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)　

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