3-methyl-5-phenylpentanol

Endpoint summary

Description of key information

ORAL
Key study:-Freeman (1980a) Acute toxicity: oral (OECD 401): LD50 2500 mg/kg bw (1800-3500 mg/kg bw) in males, 1850 mg/kg bw (1190-2870 mg/kg bw) in females (selected as the key value) and 2300 mg/kg bw (1760-3010 mg/kg bw)
INHALATION
A data waiver was submitted to address acute toxicity via the inhalatory route. Based on the known properties of the substance, exposure via inhalation is not considered to be a likely route of exposure.
DERMAL
Key study:- Freeman (1980b) Acute toxicity: dermal (similar to OECD 402): LD50 > 5000 mg/kg bw (male rats), 3100 mg/kg bw (female rats)
Supporting study:- Driscoll (1999) Acute toxicity dermal (OECD 402): LD50 > 2000 mg/kg bw (male/female rats) (read-across)

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:

1980-03-20 to 1980-04-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed in compliance with GLP to a standardised guideline with some limitations in the level of detail in the reporting of the materials and methods.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Federal Register, Volume 43, No. 247

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: TAcN(SD)fBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: Within the range of 180-280 g
- Fasting period before study: Overnight
- Housing: Singly housed in wire cages
- Diet: Ad libitum
- Water : Ad libitum
- Acclimation period: 7 days

IN-LIFE DATES: 1980-03-20 to 1980-04-05

Route of administration:

oral: gavage

Vehicle:

other: alcohol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 0.5 mL/100 g bw

Doses:

Range Finding test: 1000 and 2500 mg/kg bw administered as 5 mL/kg
Main test: 1000, 1600, 2500, 3200 and 5000 mg/kg bw

No. of animals per sex per dose:

Range finding study: 2 groups of 2 male and 2 female rats
Main test: 5 groups of 8 males and 8 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days in total.
- Frequency of observations and weighing: Animals were observed for toxic signs at 1, 3, 5 and 24 hours post dosing and twice daily (once daily on weekends) for the fourteen day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy: Animals that died and all animals that survived through the observation period underwent a gross necropsy. Survivors were killed at the end of the study using ether inhalation.

Statistics:

Probit analysis was used to calculate the LD50, performed using the method of Litchfield JT Jr & Wilcoxon F (1949) A Simplified Method of Evaluating Dose-Effect Experiments; J. Pharm. Exp. Therap., 96:99-115.

Preliminary study:

At 2500 mg/kg 1/2 male and 0/2 female animals died within the 72 hour observation period. All animals from the 1000 mg/kg group survived. Other dilutions at 10 mL/kg were used however this resulted the death of all the animals.

Sex:

female

Dose descriptor:

LD50

Effect level:

1 850 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (1190-2870 mg/kg bw)

Sex:

male

Dose descriptor:

LD50

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (1800-3500 mg/kg bw)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 300 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (1760-3010 mg/kg bw)

Mortality:

Most deaths ath the lower dose levels occurred more than 24 hours after dosing. At higher doses most deaths occurred during the first night after dosing.

Clinical signs:

other: At 1000 mg/kg bw lethargy, ataxia or adoption of the prone position were observed in 35 % of males and in all the females; the signs were observed in the first twenty four hours and survivors had recovered by 48 hours after having been dosed. Similar sign

Gross pathology:

There were no signs indicative of toxicity in any of the animals necropsied at term. In animals that died prior to scheduled termination, the only effects noted with yellow fluid (most likely test substance) in the stomach and reddish fluid in the intestines.

Table 1: Body weight and doses administered- males

MALES
1000 mg/kg bw	Animal No.	2176	2177	2178	2179	2180	2316	2314	2315	Mean
	Vol test mat. administered (mL)	1.00	1.00	1.00	0.98	0.96	1.00	1.10	1.10
	Pre-fast body weight (g)	235	232	233	218	250	228	255	257	238.5
	Dosing body weight (g)	207	207	207	195	192	203	223	225	207.4
	Terminal body weight (g)	298	303	280	278	250	321	324	329	297.9
	Gain/Loss (g)	+63	+71	+47	+60	0	+93	+69	+72	+59.4
1600 mg/kg bw	Animal No.	2181	2182	2183	2184	2185	2342	2343	2344	Mean
	Vol test mat. administered (mL)	1.00	0.91	1.00	1.10	0.97	1.10	1.20	1.10
	Pre-fast body weight (g)	238	203	227	249	209	241	268	251	235.8
	Dosing body weight (g)	209	181	201	220	193	215	235	220	209.3
	Terminal body weight (g)	284	275	281	292	D	295	D	D	285.4
	Gain/Loss (g)	+46	+72	+54	+43	-	+54	-	-	+53.8
2500 mg/kg bw	Animal No.	2186	2187	2188	2189	2190	2345	2346	2347	Mean
	Vol test mat. administered (mL)	1.10	1.20	1.20	1.10	1.00	1.10	1.00	1.20
	Pre-fast body weight (g)	248	263	252	247	227	253	231	270	248.8
	Dosing body weight (g)	222	232	234	228	202	217	200	236	221.4
	Terminal body weight (g)	298	D	307	325	D	324	D	333	317.4
	Gain/Loss (g)	+50	-	+45	+78	-	+29	-	+63	+53.0
3200 mg/kg bw	Animal No.	2191	2192	2193	2194	2195	2348	2349	2350	Mean
	Vol test mat. administered (mL)	1.10	1.00	1.10	1.20	1.10	1.00	1.10	1.20
	Pre-fast body weight (g)	243	253	241	268	238	240	248	264	249.4
	Dosing body weight (g)	215	209	214	249	218	209	212	232	219.8
	Terminal body weight (g)	D	D	D	D	D	D	D	D	-
	Gain/Loss (g)	-	-	-	-	-	-	-	-	-
5000 mg/kg bw	Animal No.	2196	2197	2198	2199	2200	2351	2352	2353	Mean
	Vol test mat. administered (mL)	1.20	1.10	1.20	1.10	1.10	1.10	1.10	1.00
	Pre-fast body weight (g)	255	243	249	237	236	258	233	238	243.6
	Dosing body weight (g)	230	217	229	208	212	224	202	204	215.8
	Terminal body weight (g)	298	D	D	D	D	D	D	D	-
	Gain/Loss (g)	+43	-	-	-	-	-	-	-	-

 

Table 2: Body weight and doses administered- females

FEMALES
1000 mg/kg bw	Animal No.	2376	2377	2378	2379	2380	2506	2507	2508	Mean
	Vol test mat. administered (mL)	0.98	1.00	0.93	1.00	0.99	1.00	0.99	0.93
	Pre-fast body weight (g)	220	233	206	225	212	228	221	206	218.9
	Dosing body weight (g)	195	206	185	205	197	203	198	185	196.8
	Terminal body weight (g)	D	281	235	D	D	237	266	D	254.8
	Gain/Loss (g)	-	+48	+29	-	-	+9	+45	-	+32.8
1600 mg/kg bw	Animal No.	2381	2382	2383	2384	2385	2533	2534	2535	Mean
	Vol test mat. administered (mL)	0.92	0.94	1.00	0.95	0.95	0.92	0.92	1.00
	Pre-fast body weight (g)	203	200	225	201	209	208	204	227	209.6
	Dosing body weight (g)	184	188	208	189	189	183	183	207	191.4
	Terminal body weight (g)	230	233	253	D	238	D	222	259	239.2
	Gain/Loss (g)	+27	+33	+28	-	+27	-	+18	+32	+27.5
2500 mg/kg bw	Animal No.	2386	2387	2388	2389	2390	2536	2537	2538	Mean
	Vol test mat. administered (mL)	0.99	0.96	0.98	0.93	0.93	0.96	0.94	0.97
	Pre-fast body weight (g)	221	210	218	209	202	217	207	213	212.1
	Dosing body weight (g)	197	191	196	186	186	191	188	193	191.0
	Terminal body weight (g)	238	D	232	D	235	D	D	D	235.0
	Gain/Loss (g)	+17	-	+14	-	+33	-	-	-	+21.3
3200 mg/kg bw	Animal No.	2391	2392	2393	2394	2395	2539	2540	2541	Mean
	Vol test mat. administered (mL)	0.99	0.98	1.00	0.97	0.96	1.00	1.00	0.99
	Pre-fast body weight (g)	216	217	221	208	212	223	233	224	219.3
	Dosing body weight (g)	198	196	202	193	191	200	208	198	198.3
	Terminal body weight (g)	D	D	D	D	D	D	D	D	-
	Gain/Loss (g)	-	-	-	-	-	-	-	-	-
5000 mg/kg bw	Animal No.	2396	2397	2398	2399	2400	2542	2543	2544	Mean
	Vol test mat. administered (mL)	0.96	0.93	1.00	1.00	1.00	0.92	0.99	1.00
	Pre-fast body weight (g)	201	195	217	216	214	204	216	217	210.0
	Dosing body weight (g)	184	178	194	193	196	184	197	199	190.6
	Terminal body weight (g)	D	D	D	D	D	D	D	D	-
	Gain/Loss (g)	-	-	-	-	-	-	-	-	-

 

Table 3: Summary of mortality by sex, day and dose level

Dose (mg/kg bw)	Sex	Day															Total/sex	Total
		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1000	Male (8)	No mortality															0	4/16
	Female (8)	0	1	3	No further mortality												4
1600	Male (8)	0	0	3	No further mortality												3	5/16
	Female (8)	1	0	0	0	1	No further mortality										2
2500	Male (8)	0	2	1	No further mortality												3	8/16
	Female (8)	0	2	3	No further mortality												5
3200	Male (8)	0	7	0	0	1	No Survivors										8	16/16
	Female (8)	1	3	3	1	No Survivors											8
5000	Male (8)	0	3	4	No further mortality												7	15/16
	Female (8)	0	5	3	No Survivors												8

 

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal doses (LD50) for test substance were 2500 mg/kg bw (1800-3500 mg/kg bw) in males and 1850 mg/kg bw (1190-2870 mg/kg bw) in females and 2300 mg/kg bw (1760-3010 mg/kg bw) combined.

Executive summary:

The acute oral toxicity of the test substance was investigated in male and female albino rats in a GLP study conducted to OECD guideline 401. Rats were doses via gastric intubation at doses of 1000, 1600, 2500, 3200 and 5000 mg/kg bw prepared as 0.5 mL/100 g bw in alcohol. The animals were observed for 14 days for mortality and any pharmacotoxic signs. The acute oral median lethal doses (LD₅₀) was determined to be 2500 mg/kg bw (1800-3500 mg/kg bw) in males and 1850 mg/kg bw (1190-2870 mg/kg bw) in females and 2300 mg/kg bw (1760-3010 mg/kg bw) combined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 850 mg/kg bw

Quality of whole database:

Two studies available with a Klimisch score of 2. The quality of the database is therefore high.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-04-05 to 1980-04-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed in compliance with GLP, and to a method similar to the standardised guideline OECD 402. Some deficiencies were present in the of the study, such as no methods to prevent the animals from ingesting the test material, a massive sensitivity difference between sexes and a lack of vehicle controls.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(no prevention of the animals ingesting the test material)

GLP compliance:

yes

Remarks:

Federal Register, Volume 43, No. 247

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: Within the weight range of 180 to 280 grams
- Housing: Individually housed in wire cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 7 days

IN-LIFE DATES: From: 1980-04-05 To: 1980-04-19

Type of coverage:

open

Vehicle:

other: alcohol

Details on dermal exposure:

TEST SITE
- Area of exposure: The back, from the scapular region to the hips
- % coverage: Less than 30%
- Type of wrap if used: The site was left open to the air

REMOVAL OF TEST SUBSTANCE
- Washing: Any excess material was removed by wiping with a clean cloth
- Time after start of exposure: 24 hours post dosing.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL/100 g bw

Duration of exposure:

24 hours

Doses:

2000, 2500, 3100, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

8 males and 8 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period. All animals were weighed prior to dosing.
- Necropsy of survivors performed: All the animals underwent a gross necropsy at the end of the experiment. the animals were killed using ether inhalation.

Statistics:

Probit analysis was performed using the method of Litchfield JT Jr & Wilcoxon F (1949) A Simplified Method of Evaluating Dose-Effect Experiments; J. Pharm. Exp. Therap., 96:99-115.

Preliminary study:

Two rats of either sex were used. Each animal received a single dose of the test article, and was observed for the next 72 hours to determine the mortality only. The doses administered were 2400 and 5000 mg/kg bw. No animals died during the 72 hour observation period following dosing at 2500 mg/kg bw. All four rats died within 24 hours after being dosed at 5000 mg/kg bw.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

3 100 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was low in the male groups with only one of eight rats dead at 3100 and 5000 mg/kg bw. The females exhibited lethality as follows: 1/8 at 2500 mg/kg bw; 4/8 at 3100 mg/kg bw; 5/8 at 4000 mg/kg bw and 8/8 at 5000 mg/kg bw.

Clinical signs:

other: Clinical signs were first noted at 2500 mg/kg bw in the female rats and 3100 mg/kg bw in the male rats. The signs were of lethargy, ataxia, tremors and soft faeces; one female died on Day 3. At higher doses, the clinical signs included ataxia, lethargy, h

Gross pathology:

At necropsy, none of the animals that survived to term had any specific signs indicative of systemic toxicity. The predominant signs in animals that died during the study were hematuria in females at 5000 mg/kg bw and a change to greater fluidity in the consistency of the intestinal contents.

Table 1: Body weights and doses administered

MALES
2000 mg/kg bw	Animal No.	2705	2706	2707	2708	2709	2710	2711	2712	Mean
	Vol test material administered (mL)	1.1	1.1	1.3	1.2	1.1	1.1	1.1	1.1
	Pre-dose body weight (g)	225	222	262	236	218	215	220	218	227.0
	Terminal body weight (g)	314	309	349	316	316	330	344	303	322.6
	Gain/Loss (g)	+89	+87	+87	+80	+98	+115	+124	+85	+95.6
2500 mg/kg bw	Animal No.	2713	2714	2715	2716	2717	2718	2719	2720	Mean
	Vol test material administered (mL)	1.3	1.1	1.1	1.2	1.3	1.3	1.2	1.2
	Pre-dose body weight (g)	262	228	226	234	256	251	240	246	242.9
	Terminal body weight (g)	350	308	319	310	353	308	320	327	324.4
	Gain/Loss (g)	+88	+80	+93	+76	+97	+57	+80	+81	+81.5
3100 mg/kg bw	Animal No.	2721	2722	2724	2725	2726	2728	2729	2730	Mean
	Vol test material administered (mL)	1.3	1.3	1.2	1.2	1.2	1.3	1.3	1.2
	Pre-dose body weight (g)	253	258	238	241	246	258	250	239	247.9
	Terminal body weight (g)	330	306	D	324	306	355	360	338	331.3
	Gain/Loss (g)	+77	+48	-	+83	+60	+97	+110	+99	+82.0
4000 mg/kg bw	Animal No.	2679	2680	2681	2682	2683	2684	2685	2686	Mean
	Vol test material administered (mL)	1.1	1.1	1.2	1.1	1.2	1.1	1.2	1.3
	Pre-dose body weight (g)	215	216	244	227	232	212	230	252	228.5
	Terminal body weight (g)	301	306	312	290	319	291	293	317	303.6
	Gain/Loss (g)	+86	+90	+68	+63	+87	+79	+63	+65	+75.1
5000 mg/kg bw	Animal No.	2687	2688	2689	2690	2691	2692	2693	2694	Mean
	Vol test material administered (mL)	1.1	1.2	1.2	1.1	1.2	1.3	1.2	1.2
	Pre-dose body weight (g)	216	226	222	220	238	254	240	234	231.3
	Terminal body weight (g)	284	275	D	318	308	280	300	301	295.1
	Gain/Loss (g)	+68	+49	-	+98	+70	+26	+60	+67	+62.6
FEMALES
2000 mg/kg bw	Animal No.	2862	2863	2864	2865	2866	2867	2868	2869	Mean
	Vol test material administered (mL)	1.2	1.1	1.2	1.3	1.2	1.3	1.1	1.0
	Pre-dose body weight (g)	249	227	232	260	240	250	215	208	235.1
	Terminal body weight (g)	259	211	230	253	261	271	234	228	243.4
	Gain/Loss (g)	+10	-16	-2	-7	+21	+21	+19	+20	+8.3
2500 mg/kg bw	Animal No.	2870	2871	2872	2873	2874	2875	2876	2877	Mean
	Vol test material administered (mL)	1.1	1.2	1.3	1.2	1.0	1.2	1.1	1.2
	Pre-dose body weight (g)	224	238	250	247	200	239	223	230	231.4
	Terminal body weight (g)	247	242	D	282	212	246	226	239	242.0
	Gain/Loss (g)	+23	+4	-	+35	+12	+7	+3	+9	+13.3
3100 mg/kg bw	Animal No.	2878	2879	2880	2881	2882	2883	2884	2885	Mean
	Vol test material administered (mL)	1.1	1.0	1.1	1.2	1.3	1.1	1.1	1.1
	Pre-dose body weight (g)	223	204	226	238	254	226	225	220	227.0
	Terminal body weight (g)	D	D	D	261	263	D	239	222	246.3
	Gain/Loss (g)	-	-	-	+23	+9	-	+14	+2	+12.0
4000 mg/kg bw	Animal No.	2854	2855	2856	2857	2858	2859	2860	2861	Mean
	Vol test material administered (mL)	1.2	1.2	1.2	1.2	1.1	1.1	1.1	1.2
	Pre-dose body weight (g)	236	232	238	230	228	228	225	247	233.0
	Terminal body weight (g)	255	247	D	225	D	D	D	D	242.3
	Gain/Loss (g)	+19	+15	-	-5	-	-	-	-	+9.7
5000 mg/kg bw	Animal No.	2786	2787	2788	2789	2790	2791	2792	2793	Mean
	Vol test material administered (mL)	1.1	1.3	1.1	1.3	1.1	1.3	1.2	1.3
	Pre-dose body weight (g)	221	248	215	248	218	248	230	247	234.4
	Terminal body weight (g)	D	D	D	D	D	D	D	D	-
	Gain/Loss (g)	-	-	-	-	-	-	-	-	-

Table 2: Mortality

Dose (mg/kg bw)	Male	%	Female	%
2000	0/8	0	0/8	0
2500	0/8	0	1/8	12.5
3100	1/8	12.5	4/8	50.0
4000	0/8	0	5/8	62.5
5000	1/8	12.5	8/8	100.0

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the dermal LD50 in albino (Sprague Dawley CD) rats was determined to be greater than 5000 mg/kg bw for males and equal to 3100 (2900 - 3320) mg/kg bw for females.

Executive summary:

Eighty male and female albino rats (8 males and 8 females per group) were dosed dermally with the test material at concentrations of 2000, 2500, 3100, 4000 and 5000 mg/kg bw prepared in alcohol. The test site was left uncovered, after 24 hours excess material was wiped off and the animals were observed for 14 days for mortality and signs of pharmacotoxicity. The acute dermal LD₅₀ was determined to be > 5000 mg/kg bw in males and 3100 (2900-3200 mg/kg bw) in females.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 100 mg/kg bw

Quality of whole database:

Two studies available with a Klimisch score of 2 (one study based on read-across). The quality of the database is therefore high.

Additional information

In line with Column 2, point 8.5.2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral and dermal routes, which is more appropriate when considering the properties of this substance.

Justification for selection of acute toxicity – oral endpoint
The key study for acute oral toxicity (Freeman, 1980a) was determined in a GLP compliant study performed in accordance with the standardised guideline OECD 401 with a sufficient level of detail to assess the quality of the presented data. The study was performed to a good standard however some limitations were present in the level of detail in the reporting of the methods and so was assigned a reliability score of 2, in accordance with Klimisch (1997) and considered suitable to fulfil the data requirement. The acute oral LD50 of the test substance was determined to be 1850 mg/kg bw (based on the female results).

The supporting study for acute oral toxicity (Anon., 1980) was performed in accordance with the standardised guideline OECD 401 with a sufficient level of detail to assess the quality of the presented data. The study was reported to a good standard and reported to an acceptable standard, although it lacks detail in certain areas, and so was assigned a reliability score of 2, in accordance with Klimisch (1997). The results of the study supported the LD50 of 2300 mg/kg bw from the key study.

Justification for selection of acute toxicity – inhalation endpoint
Data waiver has been submitted to address acute toxicity via the inhalation route.

Justification for selection of acute toxicity – dermal endpoint
The key study for acute dermal toxicity, Freeman (1980b), was determined in a GLP compliant study performed to a method similar to standardised guideline OECD 402. The study was performed to a good standard in line with good scientific principles however some limitations were present in the methods and the level of detail in the reporting and so was assigned a reliability score of 2, in accordance with Klimisch (1997), and considered suitable to fulfil the data requirement. The acute dermal LD50 of the test substance was determined to be 3100 mg/kg bw (based on the female results).

The supporting study for acute dermal toxicity (Driscoll, 1999) was a GLP compliant study performed in accordance with the standardised guideline OECD 402. The study was performed to a good standard and was assigned a reliability score of 2, in accordance with Klimisch (1997), as the study was performed on a structurally similar substance to 3-methyl-5-phenylpentanol and has been submitted on the basis of read-across. The test substance is considered sufficiently similar to be representative of the effects of 3-methyl-5-phenylpentanol. Under the conditions of the test, the acute dermal LD50 of the test substance was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

According to Regulation EC 1272/2008 and Directive 67/548/EEC, the substance meets the criteria for classification as Acute toxicity category 4 (H302: Harmful if swallowed) and Harmful (R22: Harmful if swallowed), respectively.