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Toxicity to birds

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Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
20 April 1994- 31 March 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance thiram (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance
Qualifier:
according to guideline
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and analysis of diet:
- Test diets were prepared by mixing thiram technical into a premix which was used for preparation of the final diet. Fresh diets were typically prepared twice weekly, and any diet not used inimediately on the day of preparation was stored frozen. Control diet and three test concentrations (100, 500 and 2500 ppm) were prepared beginning on April 22, 1994. Fresh or fresh-frozen diets were presented to the birds daily. Dietary concentrations were not adjusted for purity of the test substance and are presented as ppm.
- Basal diet for die adult birds and their offspring was formulated to Wildlife International Ltd. specifications by Agway Inc. The diet contained 27% protein minimum, 2.5% fat minimum and 5% fiber maximum. Five percent (weight/weight) limestone was added to the adult diet to provide a calcium source. Water was supplied by the town of Easton public water supply. Feed and water are analyzed periodically as per Wildlife International Ltd. Standard Operating Procedures. Neither the adults nor offspring received any form ofmedication in the diet during the test.
- Samples of test diets fed to northern bobwhite were analyzed for thiram technical by International Research and Development Corporation. Diet samples were collected from the 100, 500 and 2500 ppm test concentrations, and analyzed to evaluate the homogeneity of the test substance in the diet.
Test organisms (species):
Colinus virginianus
Details on test organisms:
- Test Birds: Pen-reared northern bobwhite that were apparently healthy and phenotypically indistinguishable from wild birds, were purchased from Top Flight Quall Farm, Belvidere, New Jersey 07823. All birds were from the same hatch and were 25 weeks of age at test initiation (first day of exposure to test diet). The birds were approaching their first -breeding season and had not been used in previous testing. At test initiation all birds were examined for physical injuries and general health. Birds that did not appear healthy were discarded. Sex of the birds was deterrnined by a visual examination of the feather coat.
Limit test:
no
Total exposure duration (if not single dose):
23 wk
No. of animals per sex per dose and/or stage:
16 pairs per concentration (25 weeks old)
Control animals:
yes, concurrent no treatment
Details on test conditions:
- Each treatment and control group contained sixteen pairs of birds with one male and one female per pen. Three treatment groups were fed diets containing either 100, 500 or 2500 parts per million (ppm) of thiram technical for 23 weeks, while a fourth group received thiram technical at 2500 ppm for the first ten weeks of the study, and then received control diet until adult termination. All birds were evaluated for treatment related effects upon bird health and reproduction. The fifth group was fed control diet
- For the first 7 weeks of the test the birds were held under a photoperiod of 8 hours of light per day. The photoperiod was increased to 17 hours of Iight per day at the beginning of Week 8 to induce egg laying. The adults continued on a photoperiod of 17 hours of light per day until adult termination. Eggs were collected daily from the onset of egg production and set weekly for incubation. The first eggs were set during Week 13. Weekly throughout the laying period, eggs were collected from every other pen for egg shell thickness measurements. In addition, effects upon egg production and quality, and hatching health and survivability were examined.
- The nortbern bobwhite were observed daily for mortallty, abnormal behavior, and signs of toxicity. Adult body weights were measured at test initiation, on Weeks 2, 4, 6, 8 and at adult termination. Feed consumption was normally measured for each pen daily from Monday through Friday of each week. Necropsies were performed on all adults surviving until adult termination and all adults that died during the test

Duration (if not single dose):
23 wk
Dose descriptor:
NOEC
Effect level:
500 mg/kg diet
Conc. / dose based on:
act. ingr.
Basis for effect:
other: mortaliy and other signs of toxicity, reproduction, etc...
Mortality and sub-lethal effects:
- There were no treatment related mortalities, overt signs of toxicity or treatment related effects upon body weight, feed consumption or reproductive parameters at the 100 or 500 ppm test concentrations. While there were no treatment related mortalities or effects upon adult body weight in the
2500 ppm withdrawal group, clinicai signs which may have been related to treatment and a reduction in feed consumption was observed during the first ten weeks of the study. Once the birds were placed on control diet, no further signs of toxicity were observed, and feed consumption was comparable to the control group. Additionally, the 2500 ppm withdrawal group showed no apparent effects upon reproductive performance
Effects on reproduction:
- At the 2500 ppm test concentration, clinical signs which may have been related to treatment were observed among several birds as well as effects upon body weight and feed consumption. There also were effects upon reproductive performance, with only one offspring produced during the course of the study.

Based on the results from this study, the no observed effect concentration for northern bobwhite exposed to thiram technical in the diet during this study was 500 ppm. Birds that received thiram technical at 2500 ppm for the first ten weeks of the study, and were then transferred to basal diet, demonstrated that the effects of exposure to thiram were reversible, and that no impact on reproductive success occurred

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
15.06.1995- 12.10.1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance thiram (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance
Qualifier:
according to guideline
Guideline:
EPA OTS 797.2175 (Avian Acute Oral Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
gavage
Analytical monitoring:
no
Vehicle:
no
Details on preparation and analysis of diet:
DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: The test compound was administered in suspension in deionised water by oral gavage. The dosing suspension was prepared by taking 20 g of Biosild T and mixing with vehicle to give 50 mL of 40 % w/v suspension. Animals of the control group received ion exchanged water in 5 mL/kg body weight (bw).
Test organisms (species):
Coturnix coturnix japonica
Details on test organisms:
TEST ORGANISM
- Common name: Japanese quail
- Source: Mr. Attila Solti, Pécs-Boda, Hungary
- Age at test initiation: Age: young adult animals, 10 weeks old at the beginning of the test
- Weight at test initiation: Body weights ranged from 181 to 207 g in males and from 216 to 246 g in females at study initiation
- Sexes used: males and females
- Cultural background:
- Disease free: not reported
- Kept according to standard practices: yes
- Breeding population (e.g. reproductive history): not reported
Limit test:
yes
Total exposure duration (if not single dose):
14 d
Post exposure observation period:
Acclimatisation period: 14 days
Fasting: 16 h prior to dosing
Dosing: 1 day
Post-dosing observation: 14 days
No. of animals per sex per dose and/or stage:
5 males and 5 females
Control animals:
yes
Nominal and measured doses / concentrations:
Nominal: 2000 mg test item/kg bw
Details on test conditions:
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Feeding: Broiler grower feed used by farmers was fed ad libitum from feeders fitted with scatter proof grid.
- Health (any disease or mortality observed): Not specified in the report
- Fasting period before study: 16 h


FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: 2 weeks


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Painted wire pens (BUKISZ type) (95 x 45 x 50 cm)
- Caging: group (5 males and 5 females per pen. 428 cm2/bird


NO. OF BIRDS PER REPLICATE
- For negative control: 10 birds (5 males and 5 females) per pen
- For treated: 10 birds (5 males and 5 females) per pen


NO. OF REPLICATES PER GROUP
- For negative control and for treated: One dose group and one control group with 5 males and 5 females each.


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: Minimum: 18 – 23 °C (average 20 °C)
Maximum: 19 – 31 °C (average: 23 °C)
- Relative humidity (%): 52 - 90 % (average: 76 %)
- Photoperiod: 8/16 hour light/dark cycle wit a light intensity of 54 – 120 Lux (average: 86 Lux)
- Ventilation: Ventilation system operated with TRC-N 226 type thermoventilator.
- Shielding: No data


RANGE FINDING STUDY
- Test concentrations: 2100 mg test item/kg bw
- Test conditions: 3 birds were tested.

- Results used to determine the conditions for the definitive study: No bird died during this test
Details on examinations and observations:
Mortality, clinical symptoms, body weight and feed consumption were monitored. Post-mortem examinations were conducted on all mortalities and every surviving bird was sacrificed at study termination.
Duration (if not single dose):
14 d
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
The mortality rate in the control was below 10% and the results can be considered as valid.
Executive summary:

Materials and methods: Japanese quail (Coturnix coturnix japonica) were used to evaluate the acute oral toxicity of Biosild T containing 492.5 g thiram/L. Ten birds each (five males and five females) received a single dose of 2000 mg Biosild T/kg bw or ion exchanged water at the same volume. Birds were observed for mortality and clinical symptoms for 14 days. Body weight and feed consumption were monitored on days -14, -7 (during acclimatisation period), day 0 (day of dosing), day 3, 7 and 14 (post-treatment period).
The test complies with U.S. Environmental Protection Agency (EPA) Environmental Effects Testing Guidelines, Subpart C, Par. 797.2175 (1987).

Results and discussion: No substance related mortalities were observed at dosage level 2000 mg/kg bw. During treatment one animal died due to test material getting into the windpipe.

Animals treated with the test material were lacking movement, subdued appearance and without appetite during the 3 days following treatment, then their behaviour became similar to that of the control group.

Average body weight of the animals treated with the test material was slightly below the body weight of the control for 3 days after the treatment. From this time onward until the end of the test their body weight gain reached, moreover, passed the body weight gain of the control animals.

Feed up-take of animals treated with test material was below the feed consumption of the control animals for 3 days following the treatment. From day 3 onwards after treatment up to the end of the test, no significant difference could be observed in the feed consumption between the animals.

No macroscopic alterations were found during the autopsy of animals exterminated after the post-observation period.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
11.09.1995 - 25.10.1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance thiram (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance
Qualifier:
according to guideline
Guideline:
EPA OTS 797.2175 (Avian Acute Oral Toxicity Test)
GLP compliance:
yes
Dose method:
gavage
Vehicle:
no
Test organisms (species):
Anas platyrhynchos
Details on test organisms:
TEST ORGANISM
- Common name: Mallard duck
- Source: The birds were obtained from wild animals breeder farm in Bugyi, Hungary
- Age at test initiation: young adult animals, 18 weeks old
- Weight at test initiation: Body weights ranged from 991 to 1218 g in males and from 956 to 1149 g in females
- Sexes used: both
Limit test:
yes
Total exposure duration (if not single dose):
14 d
Post exposure observation period:
Acclimatisation period: 14 days
Fasting: 17 h prior to dosing
Dosing: 1 day
Post-dosing observation: 14 days
No. of animals per sex per dose and/or stage:
10 birds (5 males and 5 females)
Control animals:
yes
Nominal and measured doses / concentrations:
Nominal: 2000 mg test item/kg bw
Details on test conditions:
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Feeding: Maize was fed ad libitum from plastic feeders (OMKER II.).
- Health (any disease or mortality observed): Not specified in the report
- Fasting period before study: 17 h


FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: 2 weeks


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Size: 4 m x 4 m x 2 m
- Caging: 10 birds (5 males and 5 females). 1.6 m2/bird



NO. OF BIRDS PER REPLICATE
- For negative control: 10 birds (5 males and 5 females) per pen
- For treated: 10 birds (5 males and 5 females) per pen


NO. OF REPLICATES PER GROUP
- For negative control and for treated: One dose group and one control group with 5 males and 5 females each.


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: Minimum: 5 – 13 °C (average 10 °C)
Maximum:13 – 26 °C (average: 21 °C)
- Relative humidity (%): 54 - 100 % (average: 85 %)
Number of rainy days: 8
Average rainfall: 7.3 mm
- Photoperiod: Natural photoperiod
- Ventilation: No data
- Shielding: No data


RANGE FINDING STUDY
- Test concentrations: 2100 mg test item/kg bw
- Test conditions: 3 birds were tested.

- Results used to determine the conditions for the definitive study: No bird died during this test
Details on examinations and observations:
Mortality and clinical symptoms were observed continuously on the day of the treatment, and then inspected daily.
Feed consumption was measured with 1 g accuracy between days -14 to -7, -7 to -1, 0 – 3, 3 – 7, 7 – 14.
Post-mortem examinations were done at study termination.
Reference substance (positive control):
no
Duration (if not single dose):
14 d
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
The mortality rate in the control was below 10% and the results can be considered as valid.
Executive summary:

Materials and methods: Mallard duck (Anas plathyrhynchos) were used to evaluate the acute oral toxicity of Biosild T containing 492.5 g thiram/L. Ten birds each (five males and five females) received a single dose of 2000 mg Biosild T/kg bw or ion exchanged water at the same volume. Birds were observed for mortality and clinical symptoms for 14 days. Body weight and feed consumption were monitored on days -14, -7 (during acclimatisation period), day 0 (day of dosing), day 3, 7 and 14 (post-treatment period).
The test complies withU.S. Environmental Protection Agency (EPA) Environmental Effects Testing Guidelines, Subpart C, Par. 797.2175 (1987).

Results and discussion: No clinical symptoms and mortalities were observed at dosage level 2000 mg/kg bw.

Average body weight and feed consumption of the animals treated with the test material were not different from the values of the control birds.

During the autopsy, four control and four treated birds had pale liver and/or pale kidneys. These examinations are often seen in young birds and were not considered to be treatment related or compound related effects.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
09.10.1995- 07.11.1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance thiram (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance
Qualifier:
according to guideline
Guideline:
OECD Guideline 205 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Details on preparation and analysis of diet:
The active substance Thiram within the product Biosild T was determined by gas chromatography with flame photometric detector.
Test organisms (species):
Coturnix coturnix japonica
Details on test organisms:
TEST ORGANISM
- Common name: Japanese quail
- Source: Mr Attila Solti breeder, Pécs-Boda, Hungary
- Age at test initiation: 11 days
- Weight at test initiation: 31 - 45 grams at randomization
- Sexes used: not determined
Limit test:
no
Total exposure duration (if not single dose):
8 d
Remarks:
last 3 days for post-mortem observations
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
Two control groups, each with 10 animals,
five dose groups, each with 10 animals
Control animals:
yes
Nominal and measured doses / concentrations:
0 (control), 78, 156, 312.5, 625 and 5000 mg test item/kg feed (nominal concentrations)
86, 155, 314, 608, 4423 mg test item/kg feed (measured concentrations) (88.5 – 110.3 % of nominal)
Details on test conditions:
ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions: same as test
- Health (any disease or mortality observed): good
- Fasting period before study: no


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Stainless steel pens (50 x 102 x 37 cm)
- Caging: group


NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 2
- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: Mean values 28 – 30 ºC
- Relative humidity (%): 39 % (mean) (30 – 50 %)
- Photoperiod: 12 – 16 h/day, with natural light (100 – 110 Lux)
- Ventilation: Yes, ventilation equipment operated with a TRC-N 226 type thermoventilator
- Shielding: No data



RANGE FINDING STUDY
- Test concentrations: 5500 mg Biosild T/kg feed (nominal)
4957 mg Biosild T/kg feed (measured)
- Test conditions: 20 Japanese quails were treated at 5500 mg/kg nominal dosage level, which was chosen on the basis of the previously performed acute toxicity study. One bird died. One control group (without test material was run in paralel.)
- Results used to determine the conditions for the definitive study: yes
Details on examinations and observations:
Mortalities and clinical observations were recorded daily during the exposure and post-exposure observation period.
Group mean feed consumption was monitored at start of the acclimatisation period on day -7, on day -3, on day 0 (start of exposure period), at the end of exposure on day 5, and finally at the end or the trial on day 8.
Group mean bodyweights were recorded on days -7, -3, 0, 5 and 8.
At termination of the study post-mortem examination was carried out on three birds from each group
Reference substance (positive control):
no
Duration (if not single dose):
5 d
Dose descriptor:
LC50
Effect level:
> 1 781 mg/kg diet
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
Because no birds died at the highest test concentration, the LC50 value of Thiram could not be determined.
The mortality rate in the control was below 10 % and the study can be considered as valid.
Executive summary:

Materials and methods:Japanese quail (Coturnix coturnix japonica) were used to evaluate the dietary toxicity of Thiram applied via the product Biosild T which contained 492.5 g Thiram/L. Test birds were fed with untreated food for 7 days (pre-treatment period). The following 5 days, five test levels of ten birds each were fed with daily dietary doses (nominal) of 78, 156, 312.5, 625 and 5000 mg test item/kg feed. Analytical findings ranged from 88.5 % to 110.3 % of the nominal quantity. Two groups of 10 birds each were fed with untreated food (control groups) (treatment period). In the post-treatment period, birds were fed again with untreated food for 3 days. Quails were observed for mortality and symptoms of toxication for the 15 days. Furthermore, the body weight and feed consumption were monitored during the test. After study termination, 3 birds of each group were sacrificed for post-mortem examination.
The test complies with OECD Guideline for Testing of Chemicals, Effects on Biotic Systems No. 205: Avian Dietary Toxicity Test (1984).

Results and discussion:No mortalities occurred at any test groups. During treatment and post observation no chemical related clinical symptoms and health damage were observed.

The mean body weight of the birds in the four low dose groups (measured values: 86 – 608 mg/kg feed) were slightly lower (3.4 – 6.0 %) than in the control group, but they were not dependent on dosage. Statistically significant difference (p 0.1 %) was observed at 4423 mg/kg feed (measured value) where the mean body weight gain was 3 % while it was 28 % in the control.

The mean feed consumption in the four low dose groups was similar to the control group during the 5 day exposure period. In the 4423 mg/kg feed group, the feed consumption was statistically significant to the control (p 1 %). This 44 % reduction in feed uptake was judged to be compound related.

The treated birds returned to control levels in weight gain and feed consumption after they were fed with Biosild T-free diet indicating recovery.

The post-mortem examinations revealed no substance related macroscopic alterations.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance thiram (CAS No. 137-26-8). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on an read-across substance
Qualifier:
according to guideline
Guideline:
OECD Guideline 205 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Anas platyrhynchos
Limit test:
yes
Total exposure duration (if not single dose):
8 d
Remarks:
last 3 days for post-mortem observations
No. of animals per sex per dose and/or stage:
Two control groups, one dose in duplicate, each with 10 animals
Control animals:
yes
Duration (if not single dose):
5 d
Dose descriptor:
LC50
Effect level:
> 2 185 mg/kg diet
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality

Description of key information

Secondary poisoning is not expected.

Key value for chemical safety assessment

Additional information

No data on toxicity of disulfiram to bird species (CAS No. 97-77-8) were available. Therefore, a conclusion based on an analogue approach had to be drawn. Several studies have investigated the toxicity of tetramethylthiuram disulfide (CAS No. 137-26-8), substance structurally and composition related to tetraethylthiuram disulfide, to birds under GLP conditions (Kalotás, 1995 (2), Zajak, 1995 (2) and Beavers et al., 1995). The results from the corresponding acute toxicity, dietary toxicity and reproduction tests showed absence of treatment-related mortality in different bird species. Full recovery from sub-lethal clinical symptoms (if present) was observed during the post-exposure observation period (3 days onwards for acute studies, 13 weeks for reproduction study).